Cleared Traditional

AVL COMPACT 1 PH/BLOOD GAS ANALYZER

K943570 · Avl Scientific Corp. · Chemistry
Aug 1994
Decision
33d
Days
Class 2
Risk

About This 510(k) Submission

K943570 is an FDA 510(k) clearance for the AVL COMPACT 1 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 August 24, 1994, 33 days after receiving the submission on July 22, 1994. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1120.

Submission Details

510(k) Number K943570 FDA.gov
FDA Decision Cleared SESE
Date Received July 22, 1994
Decision Date August 24, 1994
Days to Decision 33 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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