BIOTROL BICARBONATE (CO2) UV HP)— 510(k) K874941

Name: FDA 510(k) clearance K874941
Creator: U.S. Food and Drug Administration
Published: 1988-01-05

Substantially Equivalent

Biotrol, USA, Inc.

FDA 510(k) clearance K874941 for BIOTROL BICARBONATE (CO2) UV HP), Substantially Equivalent on 1988-01-05. Applicant: Biotrol, USA, Inc.. Device class: 2.

Clearance details

Applicant: Biotrol, USA, Inc.
Product code: Code KHS
Device class: Class 2
Regulation: 21 CFR 862.1160
Advisory panel: Clinical Chemistry
Date received: 1987-12-02
Decision date: 1988-01-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malvern, PA, US

Download summary PDF View on FDA.gov ↗

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