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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 K102153
Device Name MOBIUS ULTRASOUND IMAGING SYSTEM
Applicant
Mobisante, Inc.
14035 NE 85th Court
Redmond,  WA  98052
Applicant Contact SAILESH CHUTANI
Correspondent
Mobisante, Inc.
14035 NE 85th Court
Redmond,  WA  98052
Correspondent Contact SAILESH CHUTANI
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received07/30/2010
Decision Date 01/20/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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