BLOOD MONITOR BMM 10-4— 510(k) K831404

Substantially Equivalent

Gambro, Inc.

FDA 510(k) clearance K831404 for BLOOD MONITOR BMM 10-4, Substantially Equivalent on 1984-04-25. Applicant: Gambro, Inc.. Device class: 2.

Clearance details

Applicant: Gambro, Inc.
Product code: Code LLB
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1983-05-02
Decision date: 1984-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.