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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Uroflowmeter
510(k) Number K944972
Device Name URO-GRAM CYSTOMRTROGRAM WITH UROFLOWMETRY
Applicant
Myo/Kinetic Systems, Inc.
N84 W13562 Leon Rd.
Menomonee Falls,  WI  53051
Applicant Contact HASSAN HAMEDI
Correspondent
Myo/Kinetic Systems, Inc.
N84 W13562 Leon Rd.
Menomonee Falls,  WI  53051
Correspondent Contact HASSAN HAMEDI
Regulation Number876.1800
Classification Product Code
EXY  
Date Received10/11/1994
Decision Date 03/08/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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