Cleared Traditional

AVL COMPACT 3 PH/BLOOD GAS ANALYZER

K963964 · Avl Scientific Corp. · Chemistry
Nov 1996
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K963964 is an FDA 510(k) clearance for the AVL COMPACT 3 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 November 29, 1996, 58 days after receiving the submission on October 2, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1120.

Submission Details

510(k) Number K963964 FDA.gov
FDA Decision Cleared SESE
Date Received October 02, 1996
Decision Date November 29, 1996
Days to Decision 58 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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