Cleared Traditional

AVL OMNI MODULAR ANALYZER

K990092 · Avl Scientific Corp. · Chemistry
Jan 1999
Decision
18d
Days
Class 2
Risk

About This 510(k) Submission

K990092 is an FDA 510(k) clearance for the AVL OMNI MODULAR 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 January 29, 1999, 18 days after receiving the submission on January 11, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1120.

Submission Details

510(k) Number K990092 FDA.gov
FDA Decision Cleared SESE
Date Received January 11, 1999
Decision Date January 29, 1999
Days to Decision 18 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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