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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 K971884
Device Name ASSET APOLLO
Original Applicant
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
595 miner rd.
highland heights,  OH  44143
Original Contact elaine k keeler
Regulation Number892.1000
Classification Product Code
LNH  
Date Received05/22/1997
Decision Date 08/20/1997
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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