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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Cystometric, Electric
510(k) Number K954278
Device Name BETA MULTI-PROCEDURE MOBILE UROLOGICAL TABLE, MODEL S5005
Applicant
Beta Medical Products, Inc.
530 S. Main St., Bldg. 17
Akron,  OH  44311
Applicant Contact KEVIN BENOIT
Correspondent
Beta Medical Products, Inc.
530 S. Main St., Bldg. 17
Akron,  OH  44311
Correspondent Contact KEVIN BENOIT
Regulation Number876.4890
Classification Product Code
MMZ  
Date Received09/13/1995
Decision Date 10/02/1995
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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