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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, tomography, computed, emission
510(k) Number K983948
Device Name BEACON, MODEL 211060
Applicant
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
595 MINER RD.
HIGHLAND HEIGHTS,  OH  44143
Correspondent
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
595 MINER RD.
HIGHLAND HEIGHTS,  OH  44143
Regulation Number892.1200
Classification Product Code
KPS  
Date Received11/05/1998
Decision Date 04/16/1999
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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