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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 K040652
Device Name VUE 100 ULTRASOUND IMAGING SYSTEM
Applicant
Mobilsonic, Inc.
560 Parrott St.
San Jose,  CA  95112
Applicant Contact BAO LE
Correspondent
Mobilsonic, Inc.
560 Parrott St.
San Jose,  CA  95112
Correspondent Contact BAO LE
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received03/11/2004
Decision Date 05/17/2004
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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