FDA Product Code
FDA Product Code BTY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Anesthesiology
- 21 CFR Citation
- 868.1890
510(k) Clearances — 64 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260242 | CPETWise Platform | Medibyt , Ltd. | 2026-08-20 | Traditional | PDF ↗ |
| K242809 | Ascent Cardiorespiratory Diagnostic Software | Medical Graphics Corporation | 2024-10-17 | Traditional | PDF ↗ |
| K223629 | SpiroSphere, SpiroSphereECG, CardioSphere | Eresearchtechnology GmbH | 2024-05-28 | Traditional | PDF ↗ |
| K231561 | Pulmonary Function Tester, Model: A9 | Guangzhou Homesun Medical Technology Co., Ltd. | 2024-02-21 | Traditional | PDF ↗ |
| K222982 | Virtus Metabolic Monitor | Virtus Technology Aps | 2023-06-23 | Traditional | PDF ↗ |
| K221030 | Model 9100 PFT/DICO | Vitalograph Ireland, Ltd. | 2022-07-15 | Traditional | PDF ↗ |
| K202754 | MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU | Eresearchtechnology GmbH | 2021-01-28 | Traditional | PDF ↗ |
| K190800 | Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors | Cosmed Srl | 2020-02-06 | Traditional | PDF ↗ |
| K181912 | Ascent Cardiorespiratory Diagnostic Software | Medical Graphics Corporation | 2019-04-12 | Traditional | PDF ↗ |
| K173937 | SpiroSphere | Eresearchtechnology GmbH | 2019-02-15 | Traditional | PDF ↗ |
| K161534 | EasyOne Pro Respiratory Analysis System | Ndd Medizintechnik AG | 2017-02-22 | Traditional | PDF ↗ |
| K150888 | Shape-HF Cardiopulmonary Testing System | Shape Medical Systems, Inc. | 2016-01-21 | Traditional | PDF ↗ |
| K122699 | SENTRYSUITE PRODUCT LINE | Carefusion Germany 234 GmbH | 2012-11-19 | Traditional | PDF ↗ |
| K120635 | EASYONE PRO RESPIRATORY TESTING DEVICE | Ndd Medizitechnik AG | 2012-09-27 | Traditional | PDF ↗ |
| K113813 | SENTRYSUITE PRODUCT LINE | Carefusion Germany 234 GmbH | 2012-05-10 | Traditional | PDF ↗ |
| K111053 | SENTRYSUITE PRODUCT LINE | Carefusion Germany 234 GmbH | 2011-08-12 | Traditional | PDF ↗ |
| K091428 | EASYONE PRO RESPIRATORY ANALYSIS SYSTEM | Ndd Medizitechnik AG | 2010-01-27 | Traditional | PDF ↗ |
| K090722 | SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM | Shape Medical Systems, Inc. | 2009-03-31 | Traditional | PDF ↗ |
| K082539 | MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CT | Cardinal Health Germany 234 GmbH | 2008-12-02 | Traditional | PDF ↗ |
| K080510 | VIP PULMONARY FUNCTION SYSTEM | Viasys Healthcare GmbH | 2008-08-20 | Special | PDF ↗ |
| K080734 | FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT | Viasys Healthcare GmbH | 2008-06-26 | Traditional | PDF ↗ |
| K071753 | MASTERSCREEN PNEUMO & MASTERSCOPE | Viasys Healthcare GmbH | 2007-08-14 | Special | PDF ↗ |
| K062011 | MODIFICATION TO FLOWSCREEN | Viasys Healthcare GmbH | 2007-05-11 | Special | PDF ↗ |
| K040549 | COSMED PONY FX | Cosmed Srl | 2004-09-28 | Traditional | PDF ↗ |
| K031194 | SPIROSOFT | Viasys Healthcare GmbH | 2003-07-30 | Special | PDF ↗ |
| K020745 | COSMED MICROQUARK | Cosmed Srl | 2003-01-02 | Traditional | PDF ↗ |
| K993641 | METALYZER, MODEL 2; METALYZER, MODEL 3 | Cortex Biophysik GmbH | 2000-12-14 | Traditional | PDF ↗ |
| K000648 | SPIRO PRO | Erich Jaeger GmbH | 2000-03-29 | Special | PDF ↗ |
| K981366 | STATIC AND DYNAMIC COMPLIANCE, A RESPIRATORY MECHANICS OPTION FOR THE VMAX SERIES | Sensor Medics Corp. | 1998-10-30 | Traditional | PDF ↗ |
| K980094 | MODIFICATION TO THE OXYCONALPHA | Erich Jaeger B.V. | 1998-07-28 | Traditional | PDF ↗ |
| K961252 | DSXL DIFFUSION SPIROMETER | Inair , Ltd. | 1997-02-14 | Traditional | PDF ↗ |
| K942230 | OXYCON-ALPHA | Mijnhardt B.V. | 1995-03-20 | Traditional | PDF ↗ |
| K942211 | VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS | Sensor Medics Corp. | 1994-11-22 | Traditional | PDF ↗ |
| K932744 | FLOWSCREEN | Erich Jaeger, Inc. | 1994-03-07 | Traditional | PDF ↗ |
| K933839 | MASTER SCREEN PNUEMO | Erich Jaeger, Inc. | 1994-03-07 | Traditional | PDF ↗ |
| K933511 | UPGRADED SPIROMETER ST-90 | Futuremed Div. of Future Impex Corp. | 1994-02-10 | Traditional | PDF ↗ |
| K932278 | PFM PROFESSIONAL 7000 SPIROMETER | Advanced Medical Systems, Inc. | 1993-12-17 | Traditional | PDF ↗ |
| K921309 | MODEL 508 PATIENT MONITOR | Criticare Systems, Inc. | 1993-12-17 | Traditional | PDF ↗ |
| K930085 | VITALOGRAPH DATA STORAGE SPIROMETER | Vitalograph , Ltd. | 1993-07-26 | Traditional | PDF ↗ |
| K911358 | CMD/DLCO DIAGNOSTIC SPIROMETER | Spirometrics, Inc. | 1991-07-22 | Traditional | PDF ↗ |
| K892705 | EBS2605 INFANT HUGGER | Equilibrated Bio Systems, Inc. | 1989-10-27 | Traditional | PDF ↗ |
| K894667 | MODELS PB950 AND PB960 DATALOOP AND SPIROLOOP | Pneumedics, Inc. | 1989-10-19 | Traditional | PDF ↗ |
| K883008 | PULMONARY FORCED FLOW SYSTEM (PUFFS) | Medical Associated Services, Inc. | 1988-09-29 | Traditional | PDF ↗ |
| K881122 | UPDATED MANUAL FOR PEDS - PULMONARY EVAL. & DIAG. | Medical Associated Services, Inc. | 1988-06-10 | Traditional | PDF ↗ |
| K864836 | L.A.P. SPIROMETER | Timeter Instrument Corp. | 1987-03-06 | Traditional | PDF ↗ |
| K864087 | PEDS PULMONARY EVALUATION & DIAGNOSTIC SYSTEM | Medical Associated Services, Inc. | 1986-11-07 | Traditional | PDF ↗ |
| K863087 | SPIROLOOP-PULMONARY EXERCISE SYSTEM | Pneumedics, Inc. | 1986-10-27 | Traditional | PDF ↗ |
| K861487 | ST-90 SPIRO ANALIZER | Future Impex Corp. | 1986-06-23 | Traditional | PDF ↗ |
| K861486 | SPIROMETRY MODULE | Medical Graphics Corp. | 1986-05-19 | Traditional | PDF ↗ |
| K855068 | SPIROMETER, MODEL TS-500 PART #SLZ7534 | Teledyne Avionics Div. of Teledyne | 1986-02-05 | Traditional | PDF ↗ |
| K855069 | SPIROMETER TS-400 SLZ 7547 | Teledyne Avionics Div. of Teledyne | 1986-01-30 | Traditional | PDF ↗ |
| K854745 | CUSTO VIT PULMONARY FUNCTION ANALYSIS SYSTEM | Versacor, Inc. | 1986-01-10 | Traditional | PDF ↗ |
| K853433 | ELF | Cardio-Respiratory | 1985-11-29 | Traditional | PDF ↗ |
| K850045 | SPIROMETRICS 2453 & SMI III | Spirometrics, Inc. | 1985-02-14 | Traditional | PDF ↗ |
| K823771 | SPIROTECH 300 | Spirotech, Inc. | 1983-01-28 | Traditional | PDF ↗ |
| K823683 | VITALOGRAPH PFT PRINTER | Vitalograph , Ltd. | 1983-01-21 | Traditional | PDF ↗ |
| K821712 | INFORMED REMOTE FIELD UNIT MODEL IFM1000 | Burditt & Calkins-Siemens-Elema | 1982-07-26 | Traditional | PDF ↗ |
| K812849 | PTT-200 TELEPHONIC PULMONARY TRANSMITT | Pharmaquest Corp. | 1981-12-03 | Traditional | PDF ↗ |
| K812850 | PTT-200 PULMONARY RECEIVER/MICROPROCES | Pharmaquest Corp. | 1981-12-03 | Traditional | PDF ↗ |
| K812792 | PFT SCREENER (SYSTEM 1100) | Medical Graphics Corp. | 1981-11-27 | Traditional | PDF ↗ |
| K810712 | ELECTRONIC SPIROMETER MODEL MFR-8100 | Nihon Kohden America, Inc. | 1981-03-24 | Traditional | PDF ↗ |
| K803053 | APEXLINE OF PULMONARY FUNCT. INSTRUM. | Warren E. Collins, Inc. | 1980-12-22 | Traditional | PDF ↗ |
| K790579 | MEDISTOR II | Cybermedic, Inc. | 1979-04-04 | Traditional | PDF ↗ |
| K780584 | PULMONARY FUNCTION TESTER | Warren E. Collins, Inc. | 1978-05-16 | Traditional | PDF ↗ |
Product code BTY · Class II · Anesthesiology. Data: openFDA.