BZL · Computer, Oxygen-Uptake
Anesthesiology · 21 CFR 868.1730 · Class 2
Overview
| Product Code | BZL |
|---|---|
| Device Name | Computer, Oxygen-Uptake |
| Regulation | 21 CFR 868.1730 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 3rd-Party Reviewable | Yes |
Identification
An oxygen uptake computer is a device intended to compute the amount of oxygen consumed by a patient and may include components for determining expired gas volume and composition.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 33)
Showing 20 most recent of 33 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K200076 | Breezing Med | Tf Health Co. | Sep 25, 2020 | SESE |
| K190561 | NICU V'02 | Cosmed Nordic Aps | Sep 4, 2020 | SESE |
| K110810 | ANASCIENT BREATH MONITOR | Invoy Technologies, LLC | Jun 21, 2011 | SESE |
| K093080 | METAPHOR METABOLIC MONITOR | Treymed, Inc. | Jan 22, 2010 | SESE |
| K071533 | FITMATE SERIES | Cosmed Srl | Sep 28, 2007 | SESE |
| K070858 | EXPRESS SERIES | Medical Graphics Corp. | Apr 16, 2007 | SESE |
| K061731 | MEDGRAPHICS ULTIMA SYSTEM | Medical Graphics Corp. | Sep 6, 2006 | SESE |
| K021490 | REEVUE INDIRECT CALORIMETER, MODEL#8100 | Korr Medical Technologies, Inc. | Jan 2, 2003 | SESE |
| K021605 | MEDGEM | Healthetech, Inc. | Jun 14, 2002 | SESE |
| K010577 | BODYGEM, MODEL HB211 | Healthetech, Inc. | Jan 10, 2002 | SESE |
| K954731 | OXYLOG 2 | P.K. Morgan , Ltd. | Jan 6, 1997 | SESE |
| K924978 | 7250 METABOLIC MONITOR | Puritan Bennett Corp. | Sep 22, 1994 | SESE |
| K921565 | CARDIOPULMONARY METABOLIC MEASUEMENT CART | Quiton Instrument Co. | Aug 11, 1994 | SESE |
| K931422 | DELTATRAC(TM) II METABOLIC MONITOR | Datex Division Instrumentarium Corp. | Nov 24, 1993 | SESE |
| K922660 | PHYSIO-DYNE EASI - LAB | Physio-Dyne | Apr 8, 1993 | SESE |
| K912906 | MEDGRAPHICS PF/DX | Medical Graphics Corp. | Feb 4, 1992 | SESE |
| K895791 | OXYMAX | Columbus Instruments Intl. Corp. | Mar 28, 1990 | SESE |
| K895935 | ICOR CMU Q PLUS | Icor AB | Jan 4, 1990 | SESE |
| K895586 | VVR/Q CALORIMETER | Vita-Stat | Sep 22, 1989 | SESE |
| K874663 | MOXUS OR OCM-1 OXYGEN UPTAKE SYSTEM | Ametek/Thermox Instruments Division | May 31, 1988 | SESE |
Top Applicants
- Medical Graphics Corp. — 4 clearances
- Beckman Instruments, Inc. — 2 clearances
- Datex Division Instrumentarium Corp. — 2 clearances
- Healthetech, Inc. — 2 clearances
- Icor AB — 2 clearances
