BZK — Spirometer, Monitoring (W/Wo Alarm) Class II
FDA product code BZK covers "Spirometer, Monitoring (W/Wo Alarm)", a Class II medical device regulated under 21 CFR 868.1850. 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
- BZK
- Device Class
- Class II
- Regulation Number
- 868.1850
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K192584 | mermaid care | BEACON Caresystem Model 00002144 | December 18, 2019 |
| K192595 | respiratory motion | ExSpiron 2Xi | December 17, 2019 |
| K180788 | shenzhen mindray bio-medical electronics co | Gas Module 3 | October 24, 2018 |
| K173181 | respiratory motion | ExSpiron 1Xi | March 16, 2018 |
| K162131 | respiratory motion | ExSpiron 1Xi | May 9, 2017 |
| K130170 | respiratory motion | EXSPIRON 1XI | May 29, 2013 |
| K120087 | respiratory motion | EXSPIRON | September 26, 2012 |
| K103578 | respironics novametrix | PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST | June 2, 2011 |
| K091853 | nspire health | WRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700-021, 700-008, 700-01 | September 21, 2009 |
| K092217 | respironics novametrix | MERCURY VCO2 | August 21, 2009 |
| K091459 | respironics novametrix | PHILIPS NM3 MONITOR, MODEL 7900 | July 28, 2009 |
| K080652 | respironics novametrix | MERCURY VCO2 MODULE WITH CAPNOSTAT 5 | June 20, 2008 |
| K062754 | datascope | GAS MODULE SE, MODEL 0998-00-0481-02 | November 2, 2006 |
| K051279 | caldyne | CALDYNE, INC. EXHALOMETER EX100, MODEL EX100 | September 7, 2005 |
| K983274 | nellcor puritan bennett | STARTRACK INFANT GRAPHICS MONITOR | December 9, 1998 |
| K972086 | alexander mfg | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS311 | August 12, 1997 |
| K932098 | datex division instrumentarium | CAPNOMAC ULTIMA ANESTHESIA MONITOR | November 29, 1993 |
| K931542 | newport medical instruments | NEWPORT COMPASS EXHALED TIDAL VOLUME MONITOR | October 25, 1993 |
| K921717 | bicore monitoring systems | BICORE SMARTVALVE OCCLUSION VALVE | November 6, 1992 |
| K903674 | national medical sales | MODEL 295 ELECTRONIC RESPIROMETER | January 4, 1991 |