Skip to content

Corometrics Transcutaneous TCPO2/CO2 Module

by GE Medical Systems Information Technologies

510(k) K980756

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 6 Oct 2026.

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK980756 Date5 Nov 1998ClearedStatusActive

Official records

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  • Withdrawn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
LKD
Device class
Class II
Regulation
21 CFR Part 868.2480
Advisory committee
Anesthesiology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Corometrics Transcutaneous TcPO2/CO2 Module is a cutaneous carbon dioxide monitor designed for the continuous, non-invasive measurement of transcutaneous oxygen and carbon dioxide levels. It functions as an integrated module that utilizes the display and control capabilities of the Solar Monitor Series and Tram-Rac 4A interface.

This device is regulated under FDA 510(k) clearance K980756. It is classified as a class 2 medical device within the anesthesiology specialty.

Other devices from GE Medical Systems Information Technologies, Inc.

See all devices from GE Medical Systems Information Technologies, Inc. →