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 |
K122699 |
CAREFUSION GERMANY 234 GMBH |
SENTRYSUITE PRODUCT LINE |
11/19/2012 |
K113813 |
CAREFUSION GERMANY 234 GMBH |
SENTRYSUITE PRODUCT LINE |
05/10/2012 |
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 |
K190800 |
Cosmed Srl |
Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors |
02/06/2020 |
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 |
K173937 |
eResearchTechnology GmbH |
SpiroSphere |
02/15/2019 |
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 |
K181912 |
Medical Graphics Corporation |
Ascent Cardiorespiratory Diagnostic Software |
04/12/2019 |
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 |