Oxequip Model 34 Med*Star Oxygen Monitor
510(k) K792356
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK792356 | Date4 Dec 1979 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- CCL
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.1720
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
The Oxequip Model 34 Med*Star Oxygen Monitor is a gaseous-phase oxygen analyzer. It is designed to measure and monitor oxygen concentrations in medical gas applications.
This device is authorized under FDA 510(k) clearance K792356. It is classified as a class 2 medical device under regulation number 868.1720.
Other devices from Oxequip Health Ind.
Questions
AI-generated answers, 22 Sep 2026
What is the primary function of the Oxequip Model 34 Med*Star?
The device is a gaseous-phase oxygen analyzer specifically designed to measure and monitor oxygen concentrations within medical gas applications.
What is the regulatory status of this oxygen monitor?
The Oxequip Model 34 Med*Star is authorized under FDA 510(k) clearance K792356 and is classified as a class 2 medical device under regulation number 868.1720.
Which medical specialty is this device associated with?
This device is categorized under the anesthesiology medical specialty, as indicated by its advisory committee classification.