Cleared Traditional

ELECTRODES FOR BLOOD GAS ANALYZERS

K832981 · Analytical Products, Inc. · Chemistry
Oct 1983
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K832981 is an FDA 510(k) clearance for the ELECTRODES FOR BLOOD GAS ANALYZERS, a Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (Class II — Special Controls, product code CHL), submitted by Analytical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 28, 1983, 56 days after receiving the submission on September 2, 1983. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1120.

Submission Details

510(k) Number K832981 FDA.gov
FDA Decision Cleared SESE
Date Received September 02, 1983
Decision Date October 28, 1983
Days to Decision 56 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CHL — Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1120

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