Cleared Traditional

COMET CAPNOGRAPH MODULE

K941165 · Spacelabs, Inc. · Anesthesiology
Oct 1994
Decision
209d
Days
Class 2
Risk

About This 510(k) Submission

K941165 is an FDA 510(k) clearance for the COMET CAPNOGRAPH MODULE, a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II — Special Controls, product code CCK), submitted by Spacelabs, Inc. (Redmond, US). The FDA issued a Cleared decision on October 6, 1994, 209 days after receiving the submission on March 11, 1994. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1400.

Submission Details

510(k) Number K941165 FDA.gov
FDA Decision Cleared SESE
Date Received March 11, 1994
Decision Date October 06, 1994
Days to Decision 209 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

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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