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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, nuclear magnetic resonance imaging
510(k) Number K212673
Device Name MR 5300
Applicant
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best,  NL 5684PC
Applicant Contact Jan van de Kerkhof
Correspondent
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best,  NL 5684PC
Correspondent Contact Jan van de Kerkhof
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Code
LNI  
Date Received08/24/2021
Decision Date 11/19/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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