Cleared Traditional

DISPOSABLE CO2 GAS SAMPLING/OXYGEN DELIVERY CANNUL

K915228 · Hospitak, Inc. · Anesthesiology
Feb 1992
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K915228 is an FDA 510(k) clearance for the DISPOSABLE CO2 GAS SAMPLING/OXYGEN DELIVERY CANNUL, a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II — Special Controls, product code CCK), submitted by Hospitak, Inc. (Lindenhurst, US). The FDA issued a Cleared decision on February 11, 1992, 83 days after receiving the submission on November 20, 1991. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1400.

Submission Details

510(k) Number K915228 FDA.gov
FDA Decision Cleared SESE
Date Received November 20, 1991
Decision Date February 11, 1992
Days to Decision 83 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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