Cleared Traditional

STAT PROFILE PHOX PLUS L ANALYZER

K012058 · Nova Biomedical Corp. · Chemistry
Aug 2001
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K012058 is an FDA 510(k) clearance for the STAT PROFILE PHOX PLUS L 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 August 20, 2001, 49 days after receiving the submission on July 2, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1120.

Submission Details

510(k) Number K012058 FDA.gov
FDA Decision Cleared SESE
Date Received July 02, 2001
Decision Date August 20, 2001
Days to Decision 49 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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