Cleared Traditional

NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM

K982928 · Radiometer America, Inc. · Chemistry
Jan 1999
Decision
139d
Days
Class 2
Risk

About This 510(k) Submission

K982928 is an FDA 510(k) clearance for the NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM, a Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (Class II — Special Controls, product code CHL), submitted by Radiometer America, Inc. (Westlake, US). The FDA issued a Cleared decision on January 6, 1999, 139 days after receiving the submission on August 20, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1120.

Submission Details

510(k) Number K982928 FDA.gov
FDA Decision Cleared SESE
Date Received August 20, 1998
Decision Date January 06, 1999
Days to Decision 139 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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