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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K132147
Device Name 2D PERFUSION
Applicant
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best Noord-Brabant,  NL 5684 pc
Applicant Contact LISELOTTE KORNMANN
Correspondent
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best Noord-Brabant,  NL 5684 pc
Correspondent Contact LISELOTTE KORNMANN
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
LLZ  
Date Received07/11/2013
Decision Date 12/16/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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