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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 Doppler, Ultrasonic
510(k) Number K133277
Device Name XARIO 100
Applicant
Toshibamedical Systems Corporation
2441 Michelle Dr.
Tustin,  CA  92780
Applicant Contact CHARLEMAGNE CHUA
Correspondent
Toshibamedical Systems Corporation
2441 Michelle Dr.
Tustin,  CA  92780
Correspondent Contact CHARLEMAGNE CHUA
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received10/24/2013
Decision Date 01/17/2014
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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