Cleared Traditional

BLOOD GASES/PC02, PO2 ANALYSIS PRODUCTS

K902267 · Phoenix Diagnostics, Inc. · Chemistry
Jun 1990
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K902267 is an FDA 510(k) clearance for the BLOOD GASES/PC02, PO2 ANALYSIS PRODUCTS, a Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (Class II — Special Controls, product code CHL), submitted by Phoenix Diagnostics, Inc. (Medfield, US). The FDA issued a Cleared decision on June 12, 1990, 22 days after receiving the submission on May 21, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1120.

Submission Details

510(k) Number K902267 FDA.gov
FDA Decision Cleared SESE
Date Received May 21, 1990
Decision Date June 12, 1990
Days to Decision 22 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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