Cleared Traditional

STAT PROFILE CRITICAL CARE XPRESS ANALYZER

K020297 · Nova Biomedical Corp. · Chemistry
Jun 2002
Decision
133d
Days
Class 2
Risk

About This 510(k) Submission

K020297 is an FDA 510(k) clearance for the STAT PROFILE CRITICAL CARE XPRESS ANALYZER, a Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (Class II — Special Controls, product code CHL), submitted by Nova Biomedical Corp. (Waltham, US). The FDA issued a Cleared decision on June 10, 2002, 133 days after receiving the submission on January 28, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1120.

Submission Details

510(k) Number K020297 FDA.gov
FDA Decision Cleared SESE
Date Received January 28, 2002
Decision Date June 10, 2002
Days to Decision 133 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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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