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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,  NL 5684 PC
Applicant Contact FRANS JACOBS
Correspondent
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
VEENPLUIS 4-6
BEST,  NL 5684 PC
Correspondent 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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