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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K140399
Device Name EBM IDO VIEWER
Applicant
EBM TECHNOLOGIES USA, LLC
641 Keeaumoku St Ste 5
Honolulu,  HI  96814
Applicant Contact JOHN SU
Correspondent
EBM TECHNOLOGIES USA, LLC
641 Keeaumoku St Ste 5
Honolulu,  HI  96814
Correspondent Contact JOHN SU
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received02/18/2014
Decision Date 09/18/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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