Cleared Traditional

CAPNOMAC ULTIMA ANESTHESIA MONITOR

K905754 · Datex Division Instrumentarium Corp. · Anesthesiology
Jun 1991
Decision
175d
Days
Class 2
Risk

About This 510(k) Submission

K905754 is an FDA 510(k) clearance for the CAPNOMAC ULTIMA ANESTHESIA MONITOR, a Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.) (Class II — Special Controls, product code CBS), submitted by Datex Division Instrumentarium Corp. (Helsinki, Finland, FI). The FDA issued a Cleared decision on June 17, 1991, 175 days after receiving the submission on December 24, 1990. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1620.

Submission Details

510(k) Number K905754 FDA.gov
FDA Decision Cleared SESE
Date Received December 24, 1990
Decision Date June 17, 1991
Days to Decision 175 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

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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