Cleared Traditional

COROMETRICS MEDICAL SYST. 220 PH ANALY.

K812552 · Transidyne General Corp. · Chemistry
Sep 1981
Decision
19d
Days
Class 2
Risk

About This 510(k) Submission

K812552 is an FDA 510(k) clearance for the COROMETRICS MEDICAL SYST. 220 PH ANALY., a Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (Class II — Special Controls, product code CHL), submitted by Transidyne General Corp. (Mchenry, US). The FDA issued a Cleared decision on September 23, 1981, 19 days after receiving the submission on September 4, 1981. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1120.

Submission Details

510(k) Number K812552 FDA.gov
FDA Decision Cleared SESE
Date Received September 04, 1981
Decision Date September 23, 1981
Days to Decision 19 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

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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