BZL — Computer, Oxygen-Uptake Class II
FDA product code BZL covers "Computer, Oxygen-Uptake", a Class II medical device regulated under 21 CFR 868.1730. 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
- BZL
- Device Class
- Class II
- Regulation Number
- 868.1730
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K200076 | tf health | Breezing Med | September 25, 2020 |
| K190561 | cosmed nordic aps | NICU V'02 | September 4, 2020 |
| K110810 | invoy technologies | ANASCIENT BREATH MONITOR | June 21, 2011 |
| K093080 | treymed | METAPHOR METABOLIC MONITOR | January 22, 2010 |
| K071533 | cosmed | FITMATE SERIES | September 28, 2007 |
| K070858 | medical graphics | EXPRESS SERIES | April 16, 2007 |
| K061731 | medical graphics | MEDGRAPHICS ULTIMA SYSTEM | September 6, 2006 |
| K021490 | korr medical technologies | REEVUE INDIRECT CALORIMETER, MODEL#8100 | January 2, 2003 |
| K021605 | healthetech | MEDGEM | June 14, 2002 |
| K010577 | healthetech | BODYGEM, MODEL HB211 | January 10, 2002 |
| K954731 | p.k. morgan | OXYLOG 2 | January 6, 1997 |
| K924978 | puritan bennett | 7250 METABOLIC MONITOR | September 22, 1994 |
| K921565 | quiton instrument | CARDIOPULMONARY METABOLIC MEASUEMENT CART | August 11, 1994 |
| K931422 | datex division instrumentarium | DELTATRAC(TM) II METABOLIC MONITOR | November 24, 1993 |
| K922660 | physio-dyne | PHYSIO-DYNE EASI - LAB | April 8, 1993 |
| K912906 | medical graphics | MEDGRAPHICS PF/DX | February 4, 1992 |
| K895791 | columbus instruments intl | OXYMAX | March 28, 1990 |
| K895935 | icor | ICOR CMU Q PLUS | January 4, 1990 |
| K895586 | vita-stat | VVR/Q CALORIMETER | September 22, 1989 |
| K874663 | ametek/thermox instruments division | MOXUS OR OCM-1 OXYGEN UPTAKE SYSTEM | May 31, 1988 |