Cleared Traditional

IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL MULTI-USE CARTRIDGE

K980523 · Diametrics Medical, Inc. · Chemistry
Mar 1998
Decision
37d
Days
Class 2
Risk

About This 510(k) Submission

K980523 is an FDA 510(k) clearance for the IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL MULTI-USE CARTRIDGE, a Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (Class II — Special Controls, product code CHL), submitted by Diametrics Medical, Inc. (Roseville, US). The FDA issued a Cleared decision on March 19, 1998, 37 days after receiving the submission on February 10, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1120.

Submission Details

510(k) Number K980523 FDA.gov
FDA Decision Cleared SESE
Date Received February 10, 1998
Decision Date March 19, 1998
Days to Decision 37 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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