Cleared Abbreviated

DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE M-MINIC AND ACCESSORIES

K023454 · Datex-Ohmeda · Anesthesiology
Apr 2003
Decision
190d
Days
Class 2
Risk

About This 510(k) Submission

K023454 is an FDA 510(k) clearance for the DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE M-MINIC AND ACCESSORIES, a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II — Special Controls, product code CCK), submitted by Datex-Ohmeda (Needham, US). The FDA issued a Cleared decision on April 23, 2003, 190 days after receiving the submission on October 15, 2002. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1400.

Submission Details

510(k) Number K023454 FDA.gov
FDA Decision Cleared SESE
Date Received October 15, 2002
Decision Date April 23, 2003
Days to Decision 190 days
Submission Type Abbreviated
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CCK — Analyzer, Gas, Carbon-dioxide, Gaseous-phase
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1400

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