Cleared Traditional

AS/3(TM) ANESTHESIA MONITOR SYST INTERFACE BOARD

K935477 · Datex Division Instrumentarium Corp. · Anesthesiology
Aug 1994
Decision
259d
Days
Class 2
Risk

About This 510(k) Submission

K935477 is an FDA 510(k) clearance for the AS/3(TM) ANESTHESIA MONITOR SYST INTERFACE BOARD, a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II — Special Controls, product code CCK), submitted by Datex Division Instrumentarium Corp. (Helsinki, Finland, FI). The FDA issued a Cleared decision on August 1, 1994, 259 days after receiving the submission on November 15, 1993. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1400.

Submission Details

510(k) Number K935477 FDA.gov
FDA Decision Cleared SESE
Date Received November 15, 1993
Decision Date August 01, 1994
Days to Decision 259 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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