Cleared Traditional

AS/3 AIRWAY MODULE

K943458 · Datex Division Instrumentarium Corp. · Anesthesiology
Feb 1995
Decision
211d
Days
Class 2
Risk

About This 510(k) Submission

K943458 is an FDA 510(k) clearance for the AS/3 AIRWAY MODULE, a Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.) (Class II — Special Controls, product code CBS), submitted by Datex Division Instrumentarium Corp. (Helsinki, FI). The FDA issued a Cleared decision on February 14, 1995, 211 days after receiving the submission on July 18, 1994. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1620.

Submission Details

510(k) Number K943458 FDA.gov
FDA Decision Cleared SESE
Date Received July 18, 1994
Decision Date February 14, 1995
Days to Decision 211 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CBS — Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1620

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