Cleared Traditional

AS/3 COMPACT AIRWAY MODULE M-CAIOV

K960490 · Datex Medical Instrumentation, Inc. · Anesthesiology
May 1996
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K960490 is an FDA 510(k) clearance for the AS/3 COMPACT AIRWAY MODULE M-CAIOV, a Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.) (Class II — Special Controls, product code CBS), submitted by Datex Medical Instrumentation, Inc. (Tewksbury, US). The FDA issued a Cleared decision on May 3, 1996, 91 days after receiving the submission on February 2, 1996. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1620.

Submission Details

510(k) Number K960490 FDA.gov
FDA Decision Cleared SESE
Date Received February 02, 1996
Decision Date May 03, 1996
Days to Decision 91 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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