Cleared Traditional

CAPNOMAC ULTIMA(TM) ANESTHESIA MONITOR

K896652 · Datex Division Instrumentarium Corp. · Anesthesiology
Sep 1990
Decision
285d
Days
Class 2
Risk

About This 510(k) Submission

K896652 is an FDA 510(k) clearance for the CAPNOMAC ULTIMA(TM) ANESTHESIA MONITOR, 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 September 5, 1990, 285 days after receiving the submission on November 24, 1989. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1400.

Submission Details

510(k) Number K896652 FDA.gov
FDA Decision Cleared SESE
Date Received November 24, 1989
Decision Date September 05, 1990
Days to Decision 285 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

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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