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TC02M Electrode Adhesive Rings

by Novametrix Medical Systems, Inc.

510(k) K792010

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 7 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 7 Oct 2026. What this means

Overview

Explore the TC02M Electrode Adhesive Rings, a critical medical device designed for anesthesiology in infants not under general anesthesia. This device provides precise oxygen monitoring and cutaneous temperature control, ensuring the best possible care for delicate patients.

Regulatory status

as of registry sync 7 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK792010 Date26 Oct 1979ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 7 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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

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