UROGRAM CYSTOMETROGRAM— 510(k) K936041

Name: FDA 510(k) clearance K936041
Creator: U.S. Food and Drug Administration
Published: 1994-04-18

Substantially Equivalent

Myo/Kinetic Systems, Inc.

FDA 510(k) clearance K936041 for UROGRAM CYSTOMETROGRAM, Substantially Equivalent on 1994-04-18. Applicant: Myo/Kinetic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Myo/Kinetic Systems, Inc.
Product code: Code FEN
Device class: Class 2
Regulation: 21 CFR 876.1620
Advisory panel: Gastroenterology, Urology
Date received: 1993-12-20
Decision date: 1994-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Menomonee Falls, WI, US

Download summary PDF View on FDA.gov ↗

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