MBM(TM) MONITRAL (R) BICARBONATE MODULE— 510(k) K850179

Name: FDA 510(k) clearance K850179
Creator: U.S. Food and Drug Administration
Published: 1985-02-28

Substantially Equivalent

Hospal Medical Corp.

FDA 510(k) clearance K850179 for MBM(TM) MONITRAL (R) BICARBONATE MODULE, Substantially Equivalent on 1985-02-28. Applicant: Hospal Medical Corp.. Device class: 2.

Clearance details

Applicant: Hospal Medical Corp.
Product code: Code FKP
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1985-01-17
Decision date: 1985-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Brunswick, NJ, US

Download summary PDF View on FDA.gov ↗

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