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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K851807
Device Name RT2600(115V)(220/240V) #H4008A & H4008AE
Applicant
General Electric Co.
3920 Security Park Dr.
Rancho Cordova,  CA  95670
Applicant Contact HOWARD II
Correspondent
General Electric Co.
3920 Security Park Dr.
Rancho Cordova,  CA  95670
Correspondent Contact HOWARD II
Regulation Number892.1560
Classification Product Code
IYO  
Date Received04/30/1985
Decision Date 09/19/1985
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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