Cleared Traditional

K792155 - CO 2 METER (FDA 510(k) Clearance)

Nov 1979
Decision
34d
Days
Class 2
Risk

K792155 is an FDA 510(k) clearance for the CO 2 METER. This device is classified as a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II - Special Controls, product code CCK).

Submitted by Boehringer Laboratories (Mchenry, US). The FDA issued a Cleared decision on November 27, 1979, 34 days after receiving the submission on October 24, 1979.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1400.

Submission Details

510(k) Number K792155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1979
Decision Date November 27, 1979
Days to Decision 34 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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