Cleared Traditional

AVL OPTI R ANALYZER

K000103 · Avl Scientific Corp. · Chemistry
Mar 2000
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K000103 is an FDA 510(k) clearance for the AVL OPTI R 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 March 20, 2000, 67 days after receiving the submission on January 13, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1120.

Submission Details

510(k) Number K000103 FDA.gov
FDA Decision Cleared SESE
Date Received January 13, 2000
Decision Date March 20, 2000
Days to Decision 67 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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