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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
Applicant
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
veenpluis 4-6
best, 
Contact frans jacobs
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/18/2012
Decision Date 10/26/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
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