Product code BTY
- Device name
- Calculator, Predicted Values, Pulmonary Function
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.1890
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242809 | Ascent Cardiorespiratory Diagnostic Software | Medical Graphics Corporation | 2024-10-17 |
| K223629 | SpiroSphere, SpiroSphereECG, CardioSphere | Eresearchtechnology GmbH | 2024-05-28 |
| K231561 | Pulmonary Function Tester, Model: A9 | Guangzhou Homesun Medical Technology Co., Ltd. | 2024-02-21 |
| K222982 | Virtus Metabolic Monitor | Virtus Technology Aps | 2023-06-23 |
| K221030 | Model 9100 PFT/DICO | Vitalograph Ireland, Ltd. | 2022-07-15 |
| K202754 | MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU | Eresearchtechnology GmbH | 2021-01-28 |
| K190800 | Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors | Cosmed Srl | 2020-02-06 |
| K181912 | Ascent Cardiorespiratory Diagnostic Software | Medical Graphics Corporation | 2019-04-12 |
| K173937 | SpiroSphere | Eresearchtechnology GmbH | 2019-02-15 |
| K161534 | EasyOne Pro Respiratory Analysis System | Ndd Medizintechnik AG | 2017-02-22 |
| K150888 | Shape-HF Cardiopulmonary Testing System | Shape Medical Systems, Inc. | 2016-01-21 |
| K122699 | SENTRYSUITE PRODUCT LINE | Carefusion Germany 234 GmbH | 2012-11-19 |
| K120635 | EASYONE PRO RESPIRATORY TESTING DEVICE | Ndd Medizitechnik AG | 2012-09-27 |
| K113813 | SENTRYSUITE PRODUCT LINE | Carefusion Germany 234 GmbH | 2012-05-10 |
| K111053 | SENTRYSUITE PRODUCT LINE | Carefusion Germany 234 GmbH | 2011-08-12 |
| K091428 | EASYONE PRO RESPIRATORY ANALYSIS SYSTEM | Ndd Medizitechnik AG | 2010-01-27 |
| K090722 | SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM | Shape Medical Systems, Inc. | 2009-03-31 |
| K082539 | MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CT | Cardinal Health Germany 234 GmbH | 2008-12-02 |
| K080510 | VIP PULMONARY FUNCTION SYSTEM | Viasys Healthcare GmbH | 2008-08-20 |
| K080734 | FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT | Viasys Healthcare GmbH | 2008-06-26 |
| K071753 | MASTERSCREEN PNEUMO & MASTERSCOPE | Viasys Healthcare GmbH | 2007-08-14 |
| K062011 | MODIFICATION TO FLOWSCREEN | Viasys Healthcare GmbH | 2007-05-11 |
| K040549 | COSMED PONY FX | Cosmed Srl | 2004-09-28 |
| K031194 | SPIROSOFT | Viasys Healthcare GmbH | 2003-07-30 |
| K020745 | COSMED MICROQUARK | Cosmed Srl | 2003-01-02 |
| K993641 | METALYZER, MODEL 2; METALYZER, MODEL 3 | Cortex Biophysik GmbH | 2000-12-14 |
| K000648 | SPIRO PRO | Erich Jaeger GmbH | 2000-03-29 |
| K981366 | STATIC AND DYNAMIC COMPLIANCE, A RESPIRATORY MECHANICS OPTION FOR THE VMAX SERIES | Sensor Medics Corp. | 1998-10-30 |
| K980094 | MODIFICATION TO THE OXYCONALPHA | Erich Jaeger B.V. | 1998-07-28 |
| K961252 | DSXL DIFFUSION SPIROMETER | Inair , Ltd. | 1997-02-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 34250892908633 | Jaeger | Jaeger Medical GmbH | 2025-10-31 |
| 04057155000948 | ERT PT | eResearchTechnology GmbH | 2025-08-11 |
| 14250892909117 | Jaeger | Jaeger Medical GmbH | 2025-08-11 |
| 14250892907755 | Jaeger | Jaeger Medical GmbH | 2025-07-29 |
| 14250892907700 | Jaeger | Jaeger Medical GmbH | 2025-07-29 |
| 14250892907694 | Jaeger | Jaeger Medical GmbH | 2025-07-29 |
| 14250892907687 | Jaeger | Jaeger Medical GmbH | 2025-07-29 |
| 14250892907670 | Jaeger | Jaeger Medical GmbH | 2025-07-29 |
| 14250892907571 | Jaeger | Jaeger Medical GmbH | 2025-07-24 |
| 14250892907588 | Jaeger | Jaeger Medical GmbH | 2025-07-23 |
| 14250892907595 | Jaeger | Jaeger Medical GmbH | 2025-07-23 |
| 14250892907601 | Jaeger | Jaeger Medical GmbH | 2025-07-23 |
| 14250892907656 | Jaeger | Jaeger Medical GmbH | 2025-07-23 |
| 14250892907663 | Jaeger | Jaeger Medical GmbH | 2025-07-23 |
| 14250892907564 | Jaeger | Jaeger Medical GmbH | 2025-07-23 |
| 14250892907557 | Jaeger | Jaeger Medical GmbH | 2025-07-23 |
| 14250892907533 | Jaeger | Jaeger Medical GmbH | 2025-07-23 |
| 14250892907526 | Jaeger | Jaeger Medical GmbH | 2025-07-23 |
| 14250892903900 | Vyaire | Jaeger Medical GmbH | 2021-04-01 |
| 14250892903917 | Vyaire | Jaeger Medical GmbH | 2021-04-01 |
| 14250892903726 | Vyaire | Jaeger Medical GmbH | 2021-04-01 |
| 14250892905799 | Vyaire | Jaeger Medical GmbH | 2021-01-21 |
| 04057155000627 | MasterScope | eResearchTechnology GmbH | 2020-11-20 |
| 04250892904672 | Vyaire | Jaeger Medical GmbH | 2019-10-14 |
| 04057155000412 | ERT PT | eResearchTechnology GmbH | 2019-02-25 |
| 00853452007024 | FUTUREMED | FUTUREMED AMERICA, INC. | 2017-10-24 |
| 18052400180041 | COSMED | C O S M E D SRL | 2016-09-23 |
| 18052400180058 | COSMED | C O S M E D SRL | 2016-09-23 |
| 18052400180379 | COSMED | C O S M E D SRL | 2016-09-23 |
| 04057155000030 | MasterScope | eResearchTechnology GmbH | 2016-07-29 |