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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 K090214
Device Name VERATHON INC. BLADDERSCAN BVM 9500 ULTRASOUND
Applicant
VERATHON INCORPORATED
20001 NORTH CREEK PKWY
BOTHEL,  WA  98011
Applicant Contact KRISTIAN NIELSEN
Correspondent
VERATHON INCORPORATED
20001 NORTH CREEK PKWY
BOTHEL,  WA  98011
Correspondent Contact KRISTIAN NIELSEN
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received01/29/2009
Decision Date 03/13/2009
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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