ELLIPSE 4— 510(k) K964522

Substantially Equivalent

Andromeda Medizinische Systeme GmbH

FDA 510(k) clearance K964522 for ELLIPSE 4, Substantially Equivalent on 1997-03-21. Applicant: Andromeda Medizinische Systeme GmbH. Device class: 2.

Clearance details

Applicant: Andromeda Medizinische Systeme GmbH
Product code: Code FEN
Device class: Class 2
Regulation: 21 CFR 876.1620
Advisory panel: Gastroenterology, Urology
Date received: 1996-11-12
Decision date: 1997-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Potomac, MD, US

Download summary PDF View on FDA.gov ↗

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