TC02M Precision Gas Calibrator
by Novametrix Medical Systems, Inc.
510(k) K792011
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK792011 | Date16 Nov 1979 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KLK
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.2500
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 28 Sep 2026
The Tc02m Precision Gas Calibrator is a device used for gas calibration. It is classified as a Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia, with a device class of 2 and a product code of KLK.
The device is supplied by Novametrix Medical Systems, Inc. and has received FDA 510K authorization. It is associated with the medical specialty of Anesthesiology and has a regulation number of 868.2500. The device has a specific k number, K792011, and is registered with the FDA.
Other devices from Novametrix Medical Systems, Inc.
Questions
AI-generated answers, 28 Sep 2026
What is the TC02M Precision Gas Calibrator used for?
The TC02M Precision Gas Calibrator is used for gas calibration, specifically in the medical specialty of Anesthesiology, as a cutaneous oxygen monitor for infants not under gas anesthesia.
Is the TC02M Precision Gas Calibrator supplied sterile?
The device data does not specify if the TC02M Precision Gas Calibrator is supplied sterile, but it is classified as a device that requires calibration for accurate use.
What is the regulatory status of the TC02M Precision Gas Calibrator?
The TC02M Precision Gas Calibrator has received FDA 510K authorization, indicating it is substantially equivalent to a predicate device, with a regulation number of 868.2500.