BZK — Spirometer, Monitoring (W/Wo Alarm) Class II
FDA Device Classification
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 |