Cleared Traditional

DYNEX CO2/2000, CO2 ANALYZER

K862543 · Analytical Products, Inc. · Anesthesiology
Jul 1986
Decision
12d
Days
Class 2
Risk

About This 510(k) Submission

K862543 is an FDA 510(k) clearance for the DYNEX CO2/2000, CO2 ANALYZER, a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II — Special Controls, product code CCK), submitted by Analytical Products, Inc. (Belmont, US). The FDA issued a Cleared decision on July 15, 1986, 12 days after receiving the submission on July 3, 1986. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1400.

Submission Details

510(k) Number K862543 FDA.gov
FDA Decision Cleared SESE
Date Received July 03, 1986
Decision Date July 15, 1986
Days to Decision 12 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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