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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic, Diagnostic
510(k) Number K853249
Device Name RT3600(115V) RT3600(220/240V)
Applicant
General Electric Co.
P.O. Box 414
Milwaukee,  WI  53201
Applicant Contact JAMES M HOWARD
Correspondent
General Electric Co.
P.O. Box 414
Milwaukee,  WI  53201
Correspondent Contact JAMES M HOWARD
Regulation Number892.1570
Classification Product Code
ITX  
Date Received08/01/1985
Decision Date 12/09/1985
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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