BEDSIDE CONSOLE HA-57P/BLOOD & HEPARIN PUMP BIP-BH— 510(k) K854479

Name: FDA 510(k) clearance K854479
Creator: U.S. Food and Drug Administration
Published: 1985-12-16

Substantially Equivalent

Nipro Company, Ltd.

FDA 510(k) clearance K854479 for BEDSIDE CONSOLE HA-57P/BLOOD & HEPARIN PUMP BIP-BH, Substantially Equivalent on 1985-12-16. Applicant: Nipro Company, Ltd.. Device class: 2.

Clearance details

Applicant: Nipro Company, Ltd.
Product code: Code FKP
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1985-11-07
Decision date: 1985-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Osaka, JP

Download summary PDF View on FDA.gov ↗

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