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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 K121781
Device Name ECHONAVIGATOR RELEASE 1
Original Applicant
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
veenpluis 4-6
best,  NL 5684 pc
Original Contact frans jacobs
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/18/2012
Decision Date 10/26/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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