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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 K941996
Device Name EDGE
Applicant
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
595 MINER RD.
HIGHLAND HEIGHTS,  OH  44143
Applicant Contact ELAINE K KEELER
Correspondent
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
595 MINER RD.
HIGHLAND HEIGHTS,  OH  44143
Correspondent Contact ELAINE K KEELER
Regulation Number892.1000
Classification Product Code
LNH  
Date Received04/25/1994
Decision Date 08/25/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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