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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K082456
Device Name VERATHON INC. BLADDERSCAN ULTRASOUND SYSTEM, MODEL BVI 9600
Applicant
Verathon Incorporated
20001 N. Creek Pkwy.
Bothell,  WA  98011
Applicant Contact RICHARD A ZEINE
Correspondent
Verathon Incorporated
20001 N. Creek Pkwy.
Bothell,  WA  98011
Correspondent Contact RICHARD A ZEINE
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received08/26/2008
Decision Date 12/01/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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