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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 K090158
Device Name APLIO ARTIDA V2.0 SSH-880CV
Applicant
TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
2441 michelle dr
tustin,  CA  92780
Applicant Contact paul biggins
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received01/22/2009
Decision Date 02/06/2009
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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