Cleared Traditional

AVL MODEL 995HB PH/BLOOD GAS ANALYZER

K895317 · Avl Scientific Corp. · Chemistry
Feb 1990
Decision
156d
Days
Class 2
Risk

About This 510(k) Submission

K895317 is an FDA 510(k) clearance for the AVL MODEL 995HB 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 February 1, 1990, 156 days after receiving the submission on August 29, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1120.

Submission Details

510(k) Number K895317 FDA.gov
FDA Decision Cleared SESE
Date Received August 29, 1989
Decision Date February 01, 1990
Days to Decision 156 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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