FDA 510(k) Applications for Medical Device Product Code "EWO"
(Audiometer)

FDA 510(k) Number Applicant Device Name Decision Date
K103298 ACOUSTICON GMBH ACAM 5 AUDIOMETER SYSTEM 04/08/2011
K881760 AMERICAN ELECTROMEDICS CORP. AE1162 CLINICAL/DIAGNOSTIC AUDIOMETER 06/10/1988
K983048 AMERICAN ELECTROMEDICS CORP. AMERICAN ELECTROMEDICS QUIK TYMP 2 (QT2) TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER 11/17/1998
K972221 AMERICAN ELECTROMEDICS CORP. K 15 AUDIOMETER 09/08/1997
K970279 AMERICAN ELECTROMEDICS CORP. RACE CAR TYMPANOMETER WITH AUDIOMETER(AE-RCAUD I/QUIK TYMP 1(AE-QUIK 1)/QUICK TYMP 2(AE-QUIK 2) 03/18/1997
K951527 AMERICAN ELECTROMEDICS CORP. THE PILOT AUDIOMETER 05/03/1995
K822745 AMERICAN ELECTROMEDICS CORP. THE SCREENING TYMPANOMETER 09/30/1982
K802963 AMPLAID USA, INC. 101, 151, 161 PORTABLE AUDIOMETERS 12/19/1980
K972862 AMPLIFON S.P.A. AMPLAID 171S 10/31/1997
K971747 AMPLIFON S.P.A. AMPLAID 460 08/05/1997
K983712 AMPLIFON S.P.A. AMPLAID A311 SERIES 01/12/1999
K983915 AMPLIFON S.P.A. AMPLAID A315 AND A319 01/29/1999
K880059 AMPLUS CORP. AMPLAID 309 CLINICAL AUDIOMETER 02/23/1988
K891988 AMPLUS CORP. AMPLAID A308 CLINICAL AUDIOMETER 10/12/1989
K900096 ARTIFICAL HEARING SYSTEMS CORP. INTELLIGENT VISUAL REINFORCEMENT AUDIOMETRY (IVRA) 05/31/1990
K092089 AUDIGENCE, INC. CLARUJUST 03/10/2010
K831431 AUDIMAX AUDIOMETER MODEL-500 06/30/1983
K770823 AUTOMATED TESTING SERVICES, LTD. AUDIOMETRIC TESTING SYS., SERIES 500 05/18/1977
K822335 AXONICS, INC. AUDIT 02/07/1983
K772169 B&K INSTRUMENTS, INC. AUDIOMETER, RECORDING, AUTOMATIC 12/02/1977
K982566 BAR - ADVANCED CONTROL SYSTEMS LTD. AUTOMATIC SELF-OPERATED SCREENING AUDIOMETER DEVICE (ASAM) 10/21/1998
K942716 BELTONE ELECTRONICS CORP. AUDIO EXPERT AUDIOMETER 09/02/1994
K943616 BELTONE ELECTRONICS CORP. BELTONE PERSONAL HEARING SCREENER 07/12/1995
K940216 BELTONE ELECTRONICS CORP. BELTONE SERIES 100 AUDIOMETERS 07/29/1994
K875360 BELTONE ELECTRONICS CORP. THE BELTONE 2000 AUDIOMETER 02/17/1988
K915323 BELTONE ELECTRONICS CORP. THE BELTONE AUDIO SCOUT 05/11/1992
K963681 BENSON MEDICAL INSTRUMENTS CO. CCA-100 (MODIFIED) 10/08/1996
K981439 BENSON MEDICAL INSTRUMENTS CO. CCA-200 06/15/1998
K982441 BENSON MEDICAL INSTRUMENTS CO. CCA-220 10/09/1998
K962275 BERNAFON-MAICO, INC. MAICO MA25 SERIES II WITH SPEECH 09/05/1996
K982723 BERNAFON-MAICO, INC. MAICO MA42 10/28/1998
K971080 BERNAFON-MAICO, INC. MAICO MA52 06/06/1997
K981142 BERNAFON-MAICO, INC. MAICO MA53 04/22/1998
K122496 BIO-LOGIC SYSTEMS CORP. AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM 11/01/2012
K021801 BIO-LOGIC SYSTEMS CORP. BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS 06/27/2002
K944735 BIO-LOGIC SYSTEMS CORP. BIO-LOGIC EMAV EMISSION AVERAGING OTOACOUSTIC TEST 12/21/1994
K031352 BIO-LOGIC SYSTEMS CORP. BIO-LOGIC INSERT EARPHONES 07/16/2003
K061744 BIO-LOGIC SYSTEMS CORP. COCHLEA-SCAN / COCHLEA-SCAN PLUS 09/15/2006
K964132 BIO-LOGIC SYSTEMS CORP. MODIFICATION TO OTOACOUSTIC EMISSIONS (OAE0 TEST INSTRUMENT 05/13/1997
K961447 BIO-LOGIC SYSTEMS CORP. SCOUT SPORT - A MODIFICATION TO (FORMERLY EMAV) OTOACOUSTIC EMISSIONS (OAE) TEST INSTRUMENT 05/29/1996
K121512 BIO-LOGIC SYSTEMS CORP. SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM 07/26/2012
K974076 BIO-LOGIC SYSTEMS CORP. SPORT/AUDX OAE TEST INSTRUMENT WITH BIO-LOGIC EAR PROBE 01/22/1998
K945689 CALMED TECHNOLOGY, INC. GAME AUDIOMETERY WORD IDENTIFICATION AUDIOMETRY FOR USE WITH PRODIGIT(TM) 2000 PERSONAL DIGITAL AUDIOMETER(TM) 02/08/1995
K940999 CALMED TECHNOLOGY, INC. PRODIGIT 2000 04/22/1994
K950888 CALMED TECHNOLOGY, INC. SCREENING AUDIOMETRY WORD RECOGNITION AUDIOMETRY 03/21/1995
K854125 CRAIGWELL ELECTRONICS, LTD. CRAIGWELL AID FITTING SYSTEM AFS 01/16/1986
K973320 DECIBEL INSTRUMENTS, INC. ARTICULATE FITTING SYSTEM 11/25/1997
K841167 DEMLAR MEDICAL, INC. DEMLAR SYS I COMPUTER BASED AUDIOMETER 06/27/1984
K803072 DEMLAR MEDICAL, INC. HIGH FREQUENCY AUDIOMETER DELMAR #20-K 12/30/1980
K092244 DIAGNOSTIC GROUP LLC MA61, MA62, MA63 FAMILY OF PORTABLE AUDIOMETERS 03/01/2010
K874516 DIGITAL HEARING SYSTEMS CORP. MODEL V4 AUDIOMETER 12/14/1987
K112992 EARLOGIC CORPORATION EARLOGIC OAE TESTER 04/20/2012
K895200 ECKSTEIN BROTHERS, INC. MODEL EB-22 NOISE STIK 01/22/1990
K926336 ELECTROCAINE MEDICAL SYSTEM AUDIOSCAN 03/04/1993
K933097 ENSONIQ CORP. SOUND SELECTOR FULL-SERVICE AUDIOMETER 01/24/1994
K092111 ENTOMED AB ENTOMED SCREENING AUDIOMETER, MODEL SA201,SA202, ENTOMED DIAGNOSTIC AUDIOMETER MODEL SA203,SA204 10/02/2009
K962012 ETHICAL HEARING INSTRUMENTS ETHICAL HEARING INSTRUMENTS/WIZARD HEARING PROFILE TESTER 08/21/1996
K930553 ETYMOTIC RESEARCH CUB DIS OTOACOUSTIC EMISSIONS TEST INSTRUMENT 09/29/1993
K010165 ETYMOTIC RESEARCH ERO SCAN OAE TEST SYSTEM 03/12/2001
K980533 ETYMOTIC RESEARCH ERO-SCAN OTOACOUSTIC EMISSIONS TEST INST. (ER34) 03/23/1998
K011114 ETYMOTIC RESEARCH ETYMOTIC RESEARCH ER-10D OAE PROBE 07/03/2001
K070880 ETYMOTIC RESEARCH, INC. ER35 ERO-SCAN PRO HEARING TEST SYSTEM 06/07/2007
K112733 ETYMOTIC RESEARCH, INC. ER35 ERO-SCAN PRO HEARING TEST SYSTEM 12/16/2011
K150491 ETYMOTIC RESEARCH, INC. ER36 Series OAE Test System 03/26/2015
K024205 EVEREST BIOMEDICAL INSTRUMENTS CO. AUDIOSCREENER OAE+ABR 03/07/2003
K982642 FISCHER-ZOTH AUDIOLOGIC SYSTEMS, INC. ECHO-SCREEN 10/21/1998
K833883 FRYE ELECTRONICS, INC. DIGITAL AUDIOMETER/HEARING AID 3100 02/21/1984
K913221 FRYE ELECTRONICS, INC. TYPE FA10 AUDIOMETER 10/11/1991
K933222 FUTUREMED DIV. OF FUTURE IMPEX CORP. AUDIOMETER DA 323 11/01/1993
K933220 FUTUREMED DIV. OF FUTURE IMPEX CORP. SELECTOR SL 01 11/24/1993
K934343 GLASER INSTRUMENTS AG GLASER RT60, RT80, RT150 AUDIOMETER 01/21/1994
K081234 GN OTOMETRICS GN OTOMETRICS INSERT EARPHONES 07/14/2008
K180287 Grason-Stadler Inc. GSI Corti 05/11/2018
K172403 Grason-Stadler Inc. GSI Novus 10/20/2017
K790609 GRASON-STADLER, INC. AUDIOMETER 04/10/1979
K810583 GRASON-STADLER, INC. AUDIOMETER 04/29/1981
K843618 GRASON-STADLER, INC. AUDIOMETER 12/03/1984
K902540 GRASON-STADLER, INC. GSI 17 SCREENING AUDIOMETER 07/13/1990
K953684 GRASON-STADLER, INC. GSI 61 CLINICAL AUDIOMETER 10/27/1995
K951759 GRASON-STADLER, INC. GSI 65 COMPUTERIZED AUDIOMETER 07/06/1995
K974237 GRASON-STADLER, INC. GSI 70 AUDIOPATH SCREENER 02/10/1998
K890124 GRASON-STADLER, INC. ILO88 OTODYNAMIC ANALYZER SCREENING AUDIOMETER 07/14/1989
K790846 GRASON-STADLER, INC. MIDDLE EAR ANALYZER (IMPED. AUDIOMTR) 05/17/1979
K820715 GRASON-STADLER, INC. MIDDLE EAR ANALYZER (IMPEDANCE AUDIO 04/09/1982
K903143 HANDTRONIX, INC. OTOSCREENER-I AND OTO-SCREEN-I-P 09/19/1990
K802350 HEAR CO., INC. ATTENU-CHEK 10/23/1980
K921085 HEAR-WELL TECHNOLOGIES, INC. PROGRAMMED AUDIOMETRIC DEVICE (PAD)/RECORS (PAR) 05/15/1992
K980505 HORTMANN AG HORTMANN AMDIS-OAE OAE ANALYZER 04/07/1998
K994033 HORTMANN AG HORTMANN ECHOMASTER OAE ANALYZER 02/24/2000
K031986 ICS MEDICAL ICS MEDICAL CHARTR EP WITH ASSR AND CHARTR OAE SYSTEMS 07/24/2003
K011181 ICS MEDICAL CORP. ICS MEDICAL CHARTR OAE WITH TYMP 06/25/2001
K981327 IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE) INTERACOUSTICS MODEL AD226 DIAGNOSTIC AUDIOMETER 05/11/1998
K982249 IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE) INTERACOUSTICS MODEL AD229 DIAGNOSTIC AUDIOMETER 08/07/1998
K151025 IHEAR MEDICAL, INC. iHearTest 12/29/2015
K964426 INTELLIGENT HEARING SYSTEMS SMARTOAE 02/03/1997
K023859 INTELLIGENT HEARING SYSTEMS SMARTTROAE 01/08/2003
K060883 INTERACOUSTICS A/S PILOT TEST OR DETECTIVE AUDIOMETERS 06/23/2006
K173567 Interacoustics A/S Sera 02/14/2018
K130795 INTERACOUSTICS A/S TITAN 06/20/2013
K060539 INTERACOUSTICS A/S, ASSENS DPOAE20 , ECLIPSE 05/30/2006
K030016 INTERACOUSTICS A/S, ASSENS TEOAE25 03/28/2003
K043219 INTERACOUSTICS AS AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS 02/04/2005
K052562 INTERACOUSTICS AS ECLIPSE (CABINET NAME), TEOAE25, EP15, OR THE COMBINATION OF SYSTEMS. 12/23/2005
K090406 INTERACOUSTICS AS EP15 SOFTWARE MODULE, EP25 SOFTWARE MODULE 07/22/2009
K000184 KEDLY, INC. AUDIOSCREENER OAE 02/11/2000
K001058 KEDLY, INC. AUDIOSCREENER OAE + ABR 06/02/2000
K943215 KENNETH ULLRICH DISPOSABLE AUDIOMETER EARPHONE CUSHION COVER 05/12/1995
K781474 LIFE-TECH INSTRUMENTS, INC. PREAMPLIFIER MODELS 8101PI & 8102PI 09/07/1978
K923074 LIFE-TECH INTL., INC. DANPLEX SCREENING AUDIOMETER 09/23/1992
K934658 LUCAS GRASON-STADLER, INC. GSI 60 DPOAE SYSTEM 02/01/1994
K883478 MADSEN ELECTRONICS (CANADA) LTD. DIAGNOSTIC AUDIOMETER, MODEL MIDIMATE 602 11/17/1988
K854534 MADSEN ELECTRONICS (CANADA) LTD. DIGITAL SCREENING AUDIOMETER DSA6214 02/13/1986
K931324 MADSEN ELECTRONICS (CANADA) LTD. ORBITER 922 CLINICAL AUDIOMETER 11/19/1993
K845050 MADSEN ELECTRONICS (CANADA) LTD. UP800 A UNIVERSAL PRINTER 05/29/1985
K002200 MADSEN ELECTRONICS, INC. CAPELLA 08/25/2000
K983851 MADSEN ELECTRONICS, INC. CAPELLA COCHLEAR EMISSIONS ANALYZER 01/28/1999
K945199 MADSEN ELECTRONICS, INC. RH2000 REAL EAR MEASUREMENT SYSTEM 04/11/1995
K945032 MADSEN ELECTRONICS, INC. VOYAGER 522 02/02/1995
K896401 MADSEN NORTH AMERICA, INC. MICROMATE 304 03/27/1990
K896710 MADSEN NORTH AMERICA, INC. MIDIMATE 622 04/13/1990
K063452 MAICO DIAGNOSTICS (DIAGNOSTIC GROUP LLC) MA 55 MAESTRO 03/29/2007
K171506 Maico Diagnostics GmbH Easyscreen 08/29/2017
K890842 MAICO HEARING INSTRUMENTS, INC. 2400 AUDIOMETER, IMPEDANCE METER & HRNG. AID ANALY 06/07/1989
K890993 MAICO HEARING INSTRUMENTS, INC. AUDIOMETER AI1, ME1 AND SA1 & MASTER HEARING AID 10/12/1989
K841567 MAICO HEARING INSTRUMENTS, INC. AUDIOMETER MA728 06/27/1984
K770553 MAICO HEARING INSTRUMENTS, INC. AUDIOMETER, DIAG., ADVANCED, MA-22 03/24/1977
K770616 MAICO HEARING INSTRUMENTS, INC. AUDIOMETER, MA29, PURE TONE AIR CONDUCT. 04/08/1977
K770617 MAICO HEARING INSTRUMENTS, INC. AUDIOMETER, MA30, AIR & BONE CONDUCTION 04/07/1977
K770618 MAICO HEARING INSTRUMENTS, INC. AUDIOMETER, MA31 04/08/1977
K780382 MAICO HEARING INSTRUMENTS, INC. AUDIOMETER, PORTABLE, AIR CONDUCTION 03/14/1978
K862770 MAICO HEARING INSTRUMENTS, INC. AUDIOMETER/MASTER HEARING AID MF6 08/15/1986
K895310 MAICO HEARING INSTRUMENTS, INC. AUDIOMETER/MASTER HEARING AID, MAICO MODEL MF7 01/23/1990
K780269 MAICO HEARING INSTRUMENTS, INC. COMPUTER AUDIOMETER - MA25 02/27/1978
K780270 MAICO HEARING INSTRUMENTS, INC. COMPUTER AUDIOMETER - MA26 02/27/1978
K931322 MAICO HEARING INSTRUMENTS, INC. KS 5 - CLINICAL AUDIOMETER 08/19/1994
K926439 MAICO HEARING INSTRUMENTS, INC. MA25 - PORTABLE AUDIOMETER, MODIFICATION 08/05/1993
K853919 MAICO HEARING INSTRUMENTS, INC. MA25 PORTABLE AUDIOMETER 12/18/1985
K930112 MAICO HEARING INSTRUMENTS, INC. MAICO MA790 AUDIOMETER 08/05/1993
K911368 MAICO HEARING INSTRUMENTS, INC. MAICO MA800 AUDIOMETER 06/26/1991
K791170 MAICO HEARING INSTRUMENTS, INC. MIS AURAL ACOUSTIC SCREENER 06/25/1979
K811727 MAICO HEARING INSTRUMENTS, INC. PORTABLE AUDIOMETERS 07/15/1981
K922746 MAICO HEARING INSTRUMENTS, INC. ST 20 PORTABLE AUDIOMETER 11/05/1992
K003913 MAICO-DIAGNOSTICS HINT AUDIOMETER, OR HINT 03/16/2001
K060885 MAICO-DIAGNOSTICS MODEL MI 44 TYMPANOMETER 06/05/2006
K981511 MEDRX, INC. OTO WIZZARD 07/24/1998
K914232 MERCURY ELECTRONICS (SCOT) LTD. ASRA, SCREENING AUDIOMETER 01/31/1992
K904270 MICRO AUDIOMETRICS CORP. BIOLINK AUDIOMETER SOFTWARE ACCESSORY 10/09/1990
K883505 MICRO AUDIOMETRICS CORP. BIOMETER AUDIOMETER 08/21/1989
K924543 MICRO AUDIOMETRICS CORP. DSP SCREENING AUDIOMETER 02/26/1993
K812529 MICRO AUDIOMETRICS CORP. EARSCAN 10/14/1981
K982878 MICRO AUDIOMETRICS CORP. EARSCAN 3 11/03/1998
K913589 MICRO AUDIOMETRICS CORP. EARSCAN DSP-1 PURE TONE AUDIOMETER 11/05/1991
K913276 MICROBIO-MEDICS, INC. MICROTEK MEDICAL'S SOUND STIKS 10/21/1991
K863979 MICROSCREEN MICROSCREEN I HEARING TESTER 11/18/1986
K981460 MIMOSA ACOUSTICS, INC. CUB DIS II DPOAE MEASUREMENT SYSTEM 05/20/1998
K053216 MIMOSA ACOUSTICS, INC. HEARID WIDEBAND MIDDLE EAR POWER ANALYZER 02/10/2006
K063338 MIMOSA ACOUSTICS, INC. HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS ANALYZER 01/04/2007
K123624 MIMOSA ACOUSTICS, INC. OTOSTAT DPOAE + MEPA MEASUREMENT SYSTEM 03/28/2013
K854835 MIRACLE-EAR/DAHLBERG, INC. DAHLBERG MODEL GF MICROPROCESSOR AUDIOMETER 03/04/1986
K922383 MONITOR INSTRUMENTS, INC. THE MONITOR MODEL MI-1.2.3 TONE COUNT SCREEN AUDIO 01/15/1993
K913356 MONITOR INSTRUMENTS, INC. THE MONITOR/DEMLAR MODEL MI-5000 AUDIOMETER 12/05/1991
K890497 MONITOR/DEMLAR MODEL 20-P EXTENDED HIGH FREQUENCY AUDIOMETER 06/06/1989
K112247 NATUS MEDICAL INCORPORATED A BAER WITH ABAER I/O FUNCTION 04/02/2012
K111618 NATUS MEDICAL INCORPORATED AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION 12/28/2011
K011135 NICOLET BIOMEDICAL GSI AUDERA 07/26/2001
K862592 NICOLET BIOMEDICAL INSTRUMENTS "PHOENIX SYSTEM SEVEN." 09/16/1986
K823554 OCCUPATIONAL HEALTH, INC. ACOH WELLNESS TESTER 01/05/1983
K935719 OCCUPATIONAL HEARING SERVICES DAIL A HEARING SCREENING TEST 07/07/1994
K983352 OTODYNAMICS, LTD. ILO2088 ENCHOCHECK OR ILO2088 OTOCHECK 12/11/1998
K983350 OTODYNAMICS, LTD. ILO292 DP ECHOPORT PLUS OAE SYSTEM 12/11/1998
K983351 OTODYNAMICS, LTD. ILO292 DP ECHOPORT PLUS OAE SYSTEM 12/11/1998
K962995 OTODYNAMICS, LTD. ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PC 01/10/1997
K072033 OTODYNAMICS, LTD. OTODYNAMICS OTOPORT 11/13/2007
K143395 OTODYNAMICS, LTD. Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit 02/23/2015
K883169 OTOMETER, INC. OTOMETER PORTABLE SCREENING AUDIOMETER 12/07/1988
K133012 PATH MEDICAL GMBH SENTIERO 06/09/2014
K810537 POSITRON AUTOMATIC SCREENING AUDIOMETER 03/11/1981
K941920 PRECISION ACOUSTICS IND., INC. INTERACOUSTICS CLINICAL AUDIOMETER 09/16/1994
K943065 PRECISION ACOUSTICS IND., INC. INTERACOUSTICS CLINICAL AUDIOMETER 08/17/1994
K943066 PRECISION ACOUSTICS IND., INC. INTERACOUSTICS COMPUTER AUDIOMETER BA 20 08/24/1994
K942006 PRECISION ACOUSTICS IND., INC. INTERACOUSTICS DIAGNOSTIC AUDIOMETER 06/20/1994
K894484 PROMETEX, INC. "AUDIOTESTER" SCREENING AUDIOMETER 06/26/1990
K923013 QUALITONE ACOUSTIC APPRAISE CD-3 08/14/1992
K904544 QUALITONE ACOUSTIC APPRAISER CD-2 AUDIOMETER/MASTER HEAR.AID 10/31/1990
K923007 QUALITONE AT-2 02/26/1993
K935348 QUALITONE ODYSSEY CLINICAL AUDIOMETER 02/09/1994
K953884 QUALITONE PROPHET 10/27/1995
K904622 QUALITONE HEARING AIDS AND AUDIOMETERS HEARING CHECKER(TM), DESKTOP MODEL 09/17/1991
K884044 RESOUND CORP. AUDIOMETER DIGITAL HEARING SYSTEM 02/22/1989
K984547 RESOUND CORP. DIGITAL LGOB PROCEDURE USING RESOUND, DIGITAL 5000 SERIES HEARING AIDS 03/19/1999
K912669 RESOUND CORP. RESOUND PORTABLE PRESCRIPTIVE PROGRAMMING SYSTEM 09/16/1991
K802207 RION ACOUSTIC INSTRUMENTS, INC. RION DIAGNOSTIC AUDIOMETER 09/26/1980
K872042 SENSORY AIDS CORP. PLAYTONE AUDIOMETER 08/11/1987
K895785 SINGER MEDICAL PRODUCTS, INC. AUDIOMETER MODEL MD-4, MD-4P 12/05/1989
K894748 SINGER MEDICAL PRODUCTS, INC. IMPEDANCE ANAL/SCREENING AUDIOMETER MD-1 & MD-1P 12/05/1989
K895784 SINGER MEDICAL PRODUCTS, INC. IMPEDANCE ANALYZER/AUDIOMETER MODEL MD-3 12/05/1989
K896909 SINGER MEDICAL PRODUCTS, INC. MD5 AUTOMATIC AUDIOMETER 03/05/1990
K970555 SMITH IL0292 DP ECHOPORT 03/17/1997
K900197 SOUND LINKED DATA, INC. THE MAX SYSTEM, MODEL: BASIC, 1000,2000 AUDIOMETER 04/17/1991
K953814 SOUNDSCAPE TECHNOLOGIES, INC. OTOSCAPE 12/21/1995
K902068 STARKEY LABORATORIES, INC. "HEARING AMBASSADOR-HEAR PEN" SCREENING AUDIOMETER 08/06/1990
K964340 STARKEY LABORATORIES, INC. PORTAREM-3000, PFS-6000 01/10/1997
K802560 STARKEY LABORATORIES, INC. TINNITUS RESEARCH AUDIOMETER 11/12/1980
K780150 TELEDIAGNOSTIC SYSTEMS, INC. NEONATAL SCREENING AUDIOMETER 02/13/1978
K801325 TELEDYNE AVIONICS DIV. OF TELEDYNE CLINICAL AUDIOMETER MODEL TA-200 06/30/1980
K791467 TELEDYNE AVIONICS DIV. OF TELEDYNE TA-10 PORTABLE SCREENING AUDIOMETER 09/28/1979
K851015 TELEDYNE AVIONICS DIV. OF TELEDYNE TA-20 AUTOMATIC INDUSTIRAL AUDIOMETER 06/04/1985
K844069 TELEDYNE AVIONICS DIV. OF TELEDYNE TA-201 CLINICAL AUDIOMETER 12/03/1984
K141524 TELEEMG, LLC USA NEURO-AUDIO 03/12/2015
K891373 TRACOR INSTRUMENTS AUSTIN, INC. TRACOR RA500 AUDIOMETER 07/14/1989
K780749 TRACOR INSTRUMENTS, INC. SPEECH AUDIOMETER RA 226 05/16/1978
K851392 TRACOR INSTRUMENTS, INC. TRACOR 200 MICROPROCESSOR AUDIOMETER/TRACOR RA 200 06/20/1985
K760859 TRACOR INSTRUMENTS, INC. TRACOR MODEL RA 208 COMPLIANCE AUDIOM 10/29/1976
K790903 TRACOR INSTRUMENTS, INC. TRACOR MODEL RA-411 MICROPROCESSOR 05/31/1979
K853245 TRACOR INSTRUMENTS, INC. TRACOR MODEL RA600 MICROPROCESSOR AUDIOMETER 10/16/1985
K780450 TRACOR INSTRUMENTS, INC. TRACOR RA 410 AUDIOMETER 03/30/1978
K822414 TRACOR INSTRUMENTS, INC. TRACOR RA400 AUDIOMETER 08/30/1982
K973377 TRUTONE SIBELMED AC50D 03/10/1998
K070118 TYMPANY, INC. OTOGRAM, CA3350 03/07/2007
K031713 VIASYS HEALTHCARE, INC. AUDIOMETER, OTOACOUSTIC EMISSION, AUDITORY BRANSTEM RESPONSE ACCESS 08/12/2003
K790878 VICON INSTRUMENT CO. SCREENING AUDIOMETER, HIGH FREQUENCY 08/03/1979
K934715 VIRTUAL CORP. MODEL 222 CLINICAL AUDIOMETER 05/10/1994
K863984 VIRTUAL CORP. MODEL 320 TWO CHANNEL AUDIOMETER 11/18/1986
K911689 VIRTUAL CORP. MODEL 330 SCREENING AUDIOMETER 10/21/1991
K003364 VIVOSONIC, INC. VIVO 200 DPS VIVOSCAN 07/18/2001
K033108 VIVOSONIC, INC. VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER 10/27/2003
K884218 WELCH ALLYN, INC. AUDIOSCOPE 3 MODEL 23300 ACCESSORIES 03/10/1989


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