URO-GRAM CYSTOMRTROGRAM WITH UROFLOWMETRY— 510(k) K944972

Name: FDA 510(k) clearance K944972
Creator: U.S. Food and Drug Administration
Published: 1995-03-08

Substantially Equivalent

Myo/Kinetic Systems, Inc.

FDA 510(k) clearance K944972 for URO-GRAM CYSTOMRTROGRAM WITH UROFLOWMETRY, Substantially Equivalent on 1995-03-08. Applicant: Myo/Kinetic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Myo/Kinetic Systems, Inc.
Product code: Code EXY
Device class: Class 2
Regulation: 21 CFR 876.1800
Advisory panel: Gastroenterology, Urology
Date received: 1994-10-11
Decision date: 1995-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Menomonee Falls, WI, US

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