FDA 510(k) Applications for Medical Device Product Code "BTY"
(Calculator, Predicted Values, Pulmonary Function)

FDA 510(k) Number Applicant Device Name Decision Date
K932278 ADVANTAGE MEDICAL SYSTEMS, INC. PFM PROFESSIONAL 7000 SPIROMETER 12/17/1993
K821712 BURDITT & CALKINS-SIEMENS-ELEMA INFORMED REMOTE FIELD UNIT MODEL IFM1000 07/26/1982
K082539 CARDINAL HEALTH GERMANY 234 GMBH MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CT 12/02/2008
K853433 CARDIO-RESPIRATORY ELF 11/29/1985
K113813 CAREFUSION GERMANY 234 GMBH SENTRYSUITE PRODUCT LINE 05/10/2012
K122699 CAREFUSION GERMANY 234 GMBH SENTRYSUITE PRODUCT LINE 11/19/2012
K111053 CAREFUSION GERMANY 234 GMBH SENTRYSUITE PRODUCT LINE 08/12/2011
K993641 CORTEX BIOPHYSIK GMBH METALYZER, MODEL 2; METALYZER, MODEL 3 12/14/2000
K020745 COSMED S.R.L. COSMED MICROQUARK 01/02/2003
K040549 COSMED S.R.L. COSMED PONY FX 09/28/2004
K921309 CRITICARE SYSTEMS, INC. MODEL 508 PATIENT MONITOR 12/17/1993
K790579 CYBERMEDIC, INC. MEDISTOR II 04/04/1979
K892705 EQUILIBRATED BIO SYSTEMS, INC. EBS2605 INFANT HUGGER 10/27/1989
K980094 ERICH JAEGER B.V. MODIFICATION TO THE OXYCONALPHA 07/28/1998
K000648 ERICH JAEGER GMBH SPIRO PRO 03/29/2000
K932744 ERICH JAEGER, INC. FLOWSCREEN 03/07/1994
K933839 ERICH JAEGER, INC. MASTER SCREEN PNUEMO 03/07/1994
K861487 FUTURE IMPEX CORP. ST-90 SPIRO ANALIZER 06/23/1986
K933511 FUTUREMED DIV. OF FUTURE IMPEX CORP. UPGRADED SPIROMETER ST-90 02/10/1994
K961252 INAIR LTD. DSXL DIFFUSION SPIROMETER 02/14/1997
K864087 MEDICAL ASSOCIATED SERVICES, INC. PEDS PULMONARY EVALUATION & DIAGNOSTIC SYSTEM 11/07/1986
K883008 MEDICAL ASSOCIATED SERVICES, INC. PULMONARY FORCED FLOW SYSTEM ("PUFFS") 09/29/1988
K881122 MEDICAL ASSOCIATED SERVICES, INC. UPDATED MANUAL FOR PEDS - PULMONARY EVAL. & DIAG. 06/10/1988
K812792 MEDICAL GRAPHICS CORP. PFT SCREENER (SYSTEM 1100) 11/27/1981
K861486 MEDICAL GRAPHICS CORP. SPIROMETRY MODULE 05/19/1986
K942230 MIJNHARDT B.V. OXYCON-ALPHA 03/20/1995
K161534 NDD MEDIZINTECHNIK AG EasyOne Pro Respiratory Analysis System 02/22/2017
K091428 NDD MEDIZITECHNIK AG EASYONE PRO RESPIRATORY ANALYSIS SYSTEM 01/27/2010
K120635 NDD MEDIZITECHNIK AG EASYONE PRO RESPIRATORY TESTING DEVICE 09/27/2012
K810712 NIHON KOHDEN AMERICA, INC. ELECTRONIC SPIROMETER MODEL MFR-8100 03/24/1981
K812850 PHARMAQUEST CORP. PTT-200 PULMONARY RECEIVER/MICROPROCES 12/03/1981
K812849 PHARMAQUEST CORP. PTT-200 TELEPHONIC PULMONARY TRANSMITT 12/03/1981
K894667 PNEUMEDICS, INC. MODELS PB950 AND PB960 DATALOOP AND SPIROLOOP 10/19/1989
K863087 PNEUMEDICS, INC. SPIROLOOP-PULMONARY EXERCISE SYSTEM 10/27/1986
K981366 SENSORMEDICS CORP. STATIC AND DYNAMIC COMPLIANCE, A RESPIRATORY MECHANICS OPTION FOR THE VMAX SERIES 10/30/1998
K942211 SENSORMEDICS CORP. VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS 11/22/1994
K090722 SHAPE MEDICAL SYSTEMS, INC SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM 03/31/2009
K150888 SHAPE MEDICAL SYSTEMS, INC Shape-HF Cardiopulmonary Testing System 01/21/2016
K911358 SPIROMETRICS, INC. CMD/DLCO DIAGNOSTIC SPIROMETER 07/22/1991
K850045 SPIROMETRICS, INC. SPIROMETRICS 2453 & SMI III 02/14/1985
K823771 SPIROTECH, INC. SPIROTECH 300 01/28/1983
K855069 TELEDYNE AVIONICS DIV. OF TELEDYNE SPIROMETER TS-400 SLZ 7547 01/30/1986
K855068 TELEDYNE AVIONICS DIV. OF TELEDYNE SPIROMETER, MODEL TS-500 PART #SLZ7534 02/05/1986
K864836 TIMETER INSTRUMENT CORP. L.A.P. SPIROMETER 03/06/1987
K854745 VERSACOR, INC. CUSTO VIT PULMONARY FUNCTION ANALYSIS SYSTEM 01/10/1986
K080734 VIASYS HEALTHCARE GMBH FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT 06/26/2008
K071753 VIASYS HEALTHCARE GMBH MASTERSCREEN PNEUMO & MASTERSCOPE 08/14/2007
K062011 VIASYS HEALTHCARE GMBH MODIFICATION TO FLOWSCREEN 05/11/2007
K031194 VIASYS HEALTHCARE GMBH SPIROSOFT 07/30/2003
K080510 VIASYS HEALTHCARE GMBH VIP PULMONARY FUNCTION SYSTEM 08/20/2008
K930085 VITALOGRAPH LTD. VITALOGRAPH DATA STORAGE SPIROMETER 07/26/1993
K823683 VITALOGRAPH LTD. VITALOGRAPH PFT PRINTER 01/21/1983
K803053 WARREN E. COLLINS, INC. APEXLINE OF PULMONARY FUNCT. INSTRUM. 12/22/1980
K780584 WARREN E. COLLINS, INC. PULMONARY FUNCTION TESTER 05/16/1978


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