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Fef(Tm) End-Tidal CO2 Detector

by Fenem, Inc. 510(k)

Active United States

510(k) K883821

Overview

The FEF(TM) END-TIDAL CO2 DETECTOR is a highly advanced medical device that utilizes an analyzer to detect carbon dioxide levels in the lungs, providing vital information for anesthesia care. This device is designed for use in various clinical settings, including operating rooms and intensive care units.

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK883821 Date26 Sep 1988ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
CCK
Device Class
Class II
Regulation
21 CFR Part 868.1400
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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