Cleared Traditional

AVL 9110PH ANALYZER

K932642 · Avl Scientific Corp. · Chemistry
Oct 1993
Decision
134d
Days
Class 2
Risk

About This 510(k) Submission

K932642 is an FDA 510(k) clearance for the AVL 9110PH 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 October 14, 1993, 134 days after receiving the submission on June 2, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1120.

Submission Details

510(k) Number K932642 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 1993
Decision Date October 14, 1993
Days to Decision 134 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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