Cleared Traditional

AS/3 TM NETWORK

K933284 · Datex Division Instrumentarium Corp. · Anesthesiology
Jul 1994
Decision
370d
Days
Class 2
Risk

About This 510(k) Submission

K933284 is an FDA 510(k) clearance for the AS/3 TM NETWORK, a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II — Special Controls, product code CCK), submitted by Datex Division Instrumentarium Corp. (Helsinki, FI). The FDA issued a Cleared decision on July 11, 1994, 370 days after receiving the submission on July 6, 1993. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1400.

Submission Details

510(k) Number K933284 FDA.gov
FDA Decision Cleared SESE
Date Received July 06, 1993
Decision Date July 11, 1994
Days to Decision 370 days
Submission Type Traditional
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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