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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 K200917
Device Name Azurion R2.1
Applicant
Philips Medical Systems Nederland BV
Veenpluis 4-6
Best,  NL 5684PC
Applicant Contact Michelle Campbell
Correspondent
Philips Medical Systems Nederland BV
Veenpluis 4-6
Best,  NL 5684PC
Correspondent Contact Michelle Campbell
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
JAA  
Date Received04/06/2020
Decision Date 05/01/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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