Cleared Traditional

AVL COMPACT 2 PH/BLOOD GAS ANALYZER

K942616 · Avl Scientific Corp. · Chemistry
Jul 1994
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K942616 is an FDA 510(k) clearance for the AVL COMPACT 2 PH/BLOOD GAS ANALYZER, a Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (Class II — Special Controls, product code CHL), submitted by Avl Scientific Corp. (Roswell, US). The FDA issued a Cleared decision on July 28, 1994, 56 days after receiving the submission on June 2, 1994. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1120.

Submission Details

510(k) Number K942616 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 1994
Decision Date July 28, 1994
Days to Decision 56 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

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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