GR100F URINE FLOWMETER— 510(k) K971913

Substantially Equivalent

Albyn Medical , Ltd.

FDA 510(k) clearance K971913 for GR100F URINE FLOWMETER, Substantially Equivalent on 1997-09-19. Applicant: Albyn Medical , Ltd.. Device class: 2.

Clearance details

Applicant: Albyn Medical , Ltd.
Product code: Code EXY
Device class: Class 2
Regulation: 21 CFR 876.1800
Advisory panel: Gastroenterology, Urology
Date received: 1997-05-22
Decision date: 1997-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dingwall, Ross-Shire, GB

Download summary PDF View on FDA.gov ↗

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