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MicroGas 7650 Transcutaneous Monitor

by Linde Medical Sensors AG 2 variants

510(k) K991644

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 5 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 5 Oct 2026. What this means

Regulatory status

as of registry sync 5 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK991644 Date21 May 1999ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 5 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  • Withdrawn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

Overview

AI-generated summary, 1 Oct 2026

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

The MicroGas 7650 Transcutaneous Monitor is a Class 2 medical device classified under the FDA’s Anesthesiology category. It is designed as a transcutaneous monitor for measuring the partial pressures of oxygen and carbon dioxide through the skin of infants who are not under gas anesthesia. The device employs a sensor applied to the infant’s skin to provide continuous, non-invasive monitoring of these critical gas parameters, aiding in the assessment of respiratory function and metabolic status in neonatal care settings.

This device is supplied as a reusable medical instrument and is intended for use in clinical environments such as neonatal intensive care units (NICUs) or pediatric anesthesia settings. The MicroGas 7650 has received FDA clearance via a 510(k) submission (K991644) under the Special Review pathway, with a decision date of May 21, 1999. It adheres to regulatory standards outlined in 21 CFR 868.2500 and is classified under product code KLK. No specific sterility or MRI safety information is provided in the available data.

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