DATA ZYME CO2 PROCEDURE— 510(k) K850903

Name: FDA 510(k) clearance K850903
Creator: U.S. Food and Drug Administration
Published: 1985-04-08

Substantially Equivalent

Data Medical Associates, Inc.

FDA 510(k) clearance K850903 for DATA ZYME CO2 PROCEDURE, Substantially Equivalent on 1985-04-08. Applicant: Data Medical Associates, Inc.. Device class: 2.

Clearance details

Applicant: Data Medical Associates, Inc.
Product code: Code KHS
Device class: Class 2
Regulation: 21 CFR 862.1160
Advisory panel: Clinical Chemistry
Date received: 1985-03-05
Decision date: 1985-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington, TX, US

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