Cleared Traditional

BAYER RAPIDPOINT 400 SYSTEM

K002738 · Bayer Corp. · Chemistry
Dec 2000
Decision
109d
Days
Class 2
Risk

About This 510(k) Submission

K002738 is an FDA 510(k) clearance for the BAYER RAPIDPOINT 400 SYSTEM, a Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (Class II — Special Controls, product code CHL), submitted by Bayer Corp. (Medfield, US). The FDA issued a Cleared decision on December 19, 2000, 109 days after receiving the submission on September 1, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1120.

Submission Details

510(k) Number K002738 FDA.gov
FDA Decision Cleared SESE
Date Received September 01, 2000
Decision Date December 19, 2000
Days to Decision 109 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

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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