BTY — Calculator, Predicted Values, Pulmonary Function Class II
FDA product code BTY covers "Calculator, Predicted Values, Pulmonary Function", a Class II medical device regulated under 21 CFR 868.1890. Submissions are reviewed by the Anesthesiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- BTY
- Device Class
- Class II
- Regulation Number
- 868.1890
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K242809 | medical graphics corporation | Ascent Cardiorespiratory Diagnostic Software | October 17, 2024 |
| K223629 | eresearchtechnology | SpiroSphere, SpiroSphereECG, CardioSphere | May 28, 2024 |
| K231561 | guangzhou homesun medical technology co | Pulmonary Function Tester, Model: A9 | February 21, 2024 |
| K222982 | virtus technology aps | Virtus Metabolic Monitor | June 23, 2023 |
| K221030 | vitalograph ireland | Model 9100 PFT/DICO | July 15, 2022 |
| K202754 | eresearchtechnology | MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU | January 28, 2021 |
| K190800 | cosmed | Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors | February 6, 2020 |
| K181912 | medical graphics corporation | Ascent Cardiorespiratory Diagnostic Software | April 12, 2019 |
| K173937 | eresearchtechnology | SpiroSphere | February 15, 2019 |
| K161534 | ndd medizintechnik | EasyOne Pro Respiratory Analysis System | February 22, 2017 |
| K150888 | shape medical systems | Shape-HF Cardiopulmonary Testing System | January 21, 2016 |
| K122699 | carefusion germany 234 | SENTRYSUITE PRODUCT LINE | November 19, 2012 |
| K120635 | ndd medizitechnik | EASYONE PRO RESPIRATORY TESTING DEVICE | September 27, 2012 |
| K113813 | carefusion germany 234 | SENTRYSUITE PRODUCT LINE | May 10, 2012 |
| K111053 | carefusion germany 234 | SENTRYSUITE PRODUCT LINE | August 12, 2011 |
| K091428 | ndd medizitechnik | EASYONE PRO RESPIRATORY ANALYSIS SYSTEM | January 27, 2010 |
| K090722 | shape medical systems | SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM | March 31, 2009 |
| K082539 | cardinal health germany 234 | MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CT | December 2, 2008 |
| K080510 | viasys healthcare | VIP PULMONARY FUNCTION SYSTEM | August 20, 2008 |
| K080734 | viasys healthcare | FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT | June 26, 2008 |