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 |
| 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 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
