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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 K131241
Device Name SWIP
Applicant
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
595 MINER RD
CLEVELAND,  OH  44143
Applicant Contact SUSAN QUICK
Correspondent
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
595 MINER RD
CLEVELAND,  OH  44143
Correspondent Contact SUSAN QUICK
Regulation Number892.1000
Classification Product Code
LNH  
Date Received05/01/2013
Decision Date 08/30/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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