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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name camera, multi format, radiological
510(k) Number K141454
Models UP-D898MD, UP-X898MD
Device Name SONY DIGITAL PRINTER UP-D898MD/SONY HYBRID PRINTER UP-X898MD
Original Applicant
SONY ELECTRONICS, INC.
62 forest st. ste 300
marlborough,  MA  01752
Original Contact joanne bronikowski
Regulation Number892.2040
Classification Product Code
LMC  
Date Received06/02/2014
Decision Date 06/26/2014
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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