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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Digital Image Communications, Radiological
510(k) Number K873121
Device Name GE INTEGRATED DIAGNOSTIC SYSTEM (DRS.PRS)
Applicant
General Electric Co.
P.O. Box 414
Milwaukee,  WI  53201
Applicant Contact KROGER, PHD
Correspondent
General Electric Co.
P.O. Box 414
Milwaukee,  WI  53201
Correspondent Contact KROGER, PHD
Regulation Number892.2020
Classification Product Code
LMD  
Date Received08/11/1987
Decision Date 08/23/1988
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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