FDA 510(k) Applications for Medical Device Product Code "BTY"
(Calculator, Predicted Values, Pulmonary Function)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K082539 | CARDINAL HEALTH GERMANY 234 GMBH | MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CT | 12/02/2008 |
| 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 |
| K190800 | Cosmed Srl | Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors | 02/06/2020 |
| K202754 | eResearchTechnology GmbH | MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU | 01/28/2021 |
| K173937 | eResearchTechnology GmbH | SpiroSphere | 02/15/2019 |
| K223629 | eResearchTechnology GmbH | SpiroSphere, SpiroSphereECG, CardioSphere | 05/28/2024 |
| K980094 | ERICH JAEGER B.V. | MODIFICATION TO THE OXYCONALPHA | 07/28/1998 |
| K000648 | ERICH JAEGER GMBH | SPIRO PRO | 03/29/2000 |
| K231561 | Guangzhou Homesun Medical Technology Co., Ltd | Pulmonary Function Tester, Model: A9 | 02/21/2024 |
| K961252 | INAIR LTD. | DSXL DIFFUSION SPIROMETER | 02/14/1997 |
| K242809 | Medical Graphics Corporation | Ascent Cardiorespiratory Diagnostic Software | 10/17/2024 |
| K181912 | Medical Graphics Corporation | Ascent Cardiorespiratory Diagnostic Software | 04/12/2019 |
| 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 |
| K981366 | SENSORMEDICS CORP. | STATIC AND DYNAMIC COMPLIANCE, A RESPIRATORY MECHANICS OPTION FOR THE VMAX SERIES | 10/30/1998 |
| 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 |
| 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 |
| K222982 | Virtus Technology ApS | Virtus Metabolic Monitor | 06/23/2023 |
| K221030 | Vitalograph Ireland Ltd. | Model 9100 PFT/DICO | 07/15/2022 |
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