FDA 510(k) Applications for Medical Device Product Code "DSF"
(Recorder, Paper Chart)

FDA 510(k) Number Applicant Device Name Decision Date
K780597 ABCO DEALERS, INC. ECG PAPER, 3 CHANNEL 06/28/1978
K870538 ADVANCED MEDICAL PRODUCTS, INC. MODEL 192 PRINTER 04/23/1987
K880781 AIR-SHIELDS, INC. DATALOGGER CHART RECORDER 05/11/1988
K832754 AIR-SHIELDS, INC. MONITORING SYSTEM AS100-AS115 RECORD 12/22/1983
K803225 AMERICAN EDWARDS LABORATORIES ADVANCEMED EXAMINER 01/13/1981
K811254 AMERICAN EDWARDS LABORATORIES PAPER CHART RECORDER 07/10/1981
K870119 APEX IMAGING CORP. FIBRE OPTIC STRIP CHART RECORDER 04/10/1987
K912929 ASTRO-MED, INC. DASH IV 08/13/1991
K894736 ASTRO-MED, INC. MT96000 PAPER CHART RECORDER 12/13/1989
K792099 C-V MONITORS CORP. 50MM WRITER MODEL CVM 9529 10/26/1979
K781867 C-V MONITORS CORP. WRITER, GEMINI-3 01/05/1979
K801485 CARDIOKINETICS, INC. SERIES 602 CKG RECORDER (MODIFIED) 07/08/1980
K800851 CARDIOKINETICS, INC. SERIES 602 CKGTM RECORDER 04/24/1980
K822432 CLINICAL DATA, INC. CENTURION CHART RECORDER 11/01/1982
K884911 CORTRONIC CORP. CORTRONIC SCR1000 01/13/1989
K792105 CRITIKON COMPANY,LLC CRITIKON DUAL CHANNEL RECORDER 10/26/1979
K772052 DATASCOPE CORP. PHYSIOLOGICAL RECORDER MODEL 721A 11/22/1977
K772054 DATASCOPE CORP. PHYSIOLOGICAL RECORDER MODEL 740 11/22/1977
K885058 DATEX DIVISION INSTRUMENTARIUM CORP. CARDIOCAP(TM) DR-104 REPORTER 07/14/1989
K801830 DEL MAR AVIONICS MODEL 9300 ELECTROCARDIOVALIDATOR 08/27/1980
K820033 DIASONICS, INC. CARDIOVUE ACCESSORY CART 01/22/1982
K850365 EATON MEDICAL GROUP RECORDING ACCESSORY FOR G-2000 EKG MACH. GMP-40 RE 04/09/1985
K851625 EATON MEDICAL GROUP SCX-10 SINGLE CHANNEL RECORDER ACCESS. FOR G-2000 11/19/1985
K851626 EATON MEDICAL GROUP SCX-35 THREE CHANNEL ACCESS. FOR MODULE G-2000 ELE 06/26/1985
K910871 EDENTEC CORP. EDENTEC DIGITAL CHARTER MODEL 3710 08/29/1991
K884388 EDENTEC CORP. EDENTEC MODEL 4700 SCANNER 01/10/1989
K893561 EDENTEC CORP. EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM. 08/25/1989
K883315 EDENTEC CORP. EDENTRACE MULTI-CHARTER MODEL 3700 12/28/1988
K761077 ELDECO TREND ANALYZER 12/28/1976
K890142 EMS MEDICAL, INC. A10 ULTRASCOPE RECORDER 02/06/1989
K852487 FUKUDA DENSHI USA, INC. FUKUDA DENSHI MODEL AU-5001-5003 THERMAL 09/19/1985
K843836 FUKUDA DENSHI USA, INC. THERMAL GRAYSCALE RF-100 10/19/1984
K780677 G & W APPLIED SCIENCE LABORATORIES 4600 RECORDER 05/17/1978
K901385 GABRIEL MEDICAL, INC. GABRIEL MEDICAL CLS THERMAL RECORDER 05/09/1990
K823210 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MODEL 525 NEO-TRAK NEONATAL RECORDER 11/24/1982
K855045 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MODEL 535 NEO-TRAK RECORDER 05/16/1986
K905856 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MODEL 556 MONITOR 01/11/1991
K862596 GENERAL DEVICES DR-2C (MODIFICATION) 09/26/1986
K902586 GRI MEDICAL PRODUCTS, INC. GRI LASERGRAPH(TM) ECG PAPER 06/22/1990
K821612 HEALTHDYNE, INC. MODEL 16800 TREND RECORDER 07/14/1982
K761055 HEWLETT-PACKARD CO. CALCULATOR PLOTTER (MODEL 9872A) 12/09/1976
K830315 HEWLETT-PACKARD CO. DUAL CHANNEL RECORDER #78574A 03/31/1983
K872822 HEWLETT-PACKARD CO. MODEL 78576A PAPER CHART RECORDER 11/04/1987
K760539 HEWLETT-PACKARD CO. RECORDER (#78640A) 09/09/1976
K772048 HEWLETT-PACKARD CO. SINGLE & DUAL CHANNEL RECORDER 11/09/1977
K810166 HONEYWELL, INC. 1,2,3 CHANNELL RECORDERS (AR150,AR250,-) 02/25/1981
K810169 HONEYWELL, INC. CENTRAL STATION CONTROLLER AC100/CE100 02/25/1981
K902230 HONEYWELL, INC. COLORADO COLOR IMAGING RECORDER 06/19/1990
K780640 HONEYWELL, INC. DRY SILVER PROCESSOR MODEL 1226 04/28/1978
K790825 HONEYWELL, INC. LS-8 VISICORDER 05/31/1979
K810167 HONEYWELL, INC. SINGLE CHANNELL RECORDER AR110 02/25/1981
K770342 HUDSON OXYGEN THERAPY SALES CO. RECORDER, CHART, MODEL 5536 03/01/1977
K770946 INSTRUMENTATION LABORATORY CO. RECORD, MODEL 702, I.L. 07/05/1977
K821173 INSTRUMENTS FOR CARDIAC RESEARCH EVENTMASTER 3 HOLTER EVENT SCANNER 05/18/1982
K771372 IREX CORP. SYSTEM II 08/04/1977
K832998 LITTON MEDICAL ELECTRONICS 2-CHANNEL RECORDER 06/01/1984
K833000 LITTON MEDICAL ELECTRONICS I-CHANNEL RECORDER 06/01/1984
K832012 LITTON MEDICAL ELECTRONICS MEDICAL ELECTRONICS-PRINTER CLOCK 10/31/1983
K780338 LKB INSTRUMENTS, INC. MINYSTAG MN-1 03/15/1978
K801549 MEDASONICS, INC. MODEL R11 SINGLE CHANNEL CHART RECORDER 07/14/1980
K812608 MEDASONICS, INC. VASCULAB #R12B 10/02/1981
K884897 MENNEN MEDICAL, INC. FOUR-CHANNEL/EIGHT-CHANNEL THERMAL ARRAY RECORDER 03/09/1989
K781873 MIDWEST ANALOG & DIGITAL, INC. RECORDER, STRIP CHART WITH PRINTER 01/05/1979
K833656 NARCO BIO-SYSTEMS NARCOTRACE 40 - NT40 05/09/1984
K854866 NIHON KOHDEN AMERICA, INC. LONG TERM RECORDER RAG 1200 04/09/1986
K881831 NIHON KOHDEN AMERICA, INC. WS 800R THERMAL ARRAY RECORDER 07/14/1988
K850487 NOVAMETRIX MEDICAL SYSTEMS, INC. NOVAMETRIX 350 RECORDER-PAPER CHART RECORDER 03/29/1985
K811453 NOVAMETRIX MEDICAL SYSTEMS, INC. NOVATRACER RECORDER 07/10/1981
K851274 OHMEDA MEDICAL OHMEDA MODEL 0001/0003 RECORDER 05/15/1985
K781115 OUTPUT, INC. PRINTER, DIGITAL 10/06/1978
K870039 PAR MICROSYSTEMS CORP. IMAGENET DIGITAL OPHTHALMIC IMAGING SYSTEM 02/12/1987
K831134 PHOENIX CORP. PHOENIX 60/60 PROCESSOR MODULE 11/07/1983
K760676 PHYSIO-CONTROL CORP. LIFEPAK 5 CARDIOSCOPE-RECORDER MODULE 10/13/1976
K881346 PHYSIO-CONTROL CORP. LIFESTAT 1600 PRINTER 06/09/1988
K880554 PHYSIO-CONTROL CORP. VSM(R) R2 PAPER CHART RECORDER 05/06/1988
K894607 PROTOCOL SYSTEMS, INC. PAQ10 PAPER CHART RECORDER 10/26/1989
K830321 RAE MEDICAL CORP. VENTURE II MONITORING SYSTEM 06/03/1983
K895111 S & W MEDICO TEKNIK TYPE 9541 RECORDER, PAPER CHART 01/26/1990
K822983 SIEMENS CORP. MINGOCARD 7 & MINGOPHONE 7 11/24/1982
K822978 SIEMENS CORP. MINGOGRAF 4, MINGO CARD 4 & MINOCARD 3 12/15/1982
K863331 SIEMENS MEDICAL SOLUTIONS USA, INC. "SIREDOC 60" AND "SIREDOC 220" 10/06/1986
K850146 SIEMENS MEDICAL SOLUTIONS USA, INC. SIREDOC, PAPER CHART RECORDER 02/12/1985
K890711 SOMATICS, INC. DUAL GRAPH (TM) RECORDER-MONITOR 06/02/1989
K811540 SPACELABS, INC. SPACELABS' SYSTEM AUTORECORDER 08/13/1981
K772333 TELECTRONICS, INC. RECORDER, PAPER, ECG 02/13/1978
K780245 WATERS ASSOC., INC. RECORDER, RE-100P HOT STYLUS STRIP CHART 03/27/1978
K894922 WESTERN GRAPHTEC WR3500 AND WR3600 SERIES RECORDERS 01/26/1990


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