Cleared Traditional

K982277 - MODIFICATION TO STAT PROFILE PHOX BLOOD GAS ANALYZER (K980991)
(FDA 510(k) Clearance)

K982277 · Nova Biomedical Corp. · Chemistry
Jul 1998
Decision
23d
Days
Class 2
Risk

K982277 is an FDA 510(k) clearance for the MODIFICATION TO STAT PROFILE PHOX BLOOD GAS ANALYZER (K980991), 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 July 22, 1998, 23 days after receiving the submission on June 29, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1120.

Submission Details

510(k) Number K982277 FDA.gov
FDA Decision Cleared SESE
Date Received June 29, 1998
Decision Date July 22, 1998
Days to Decision 23 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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