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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 Doppler, Ultrasonic
510(k) Number K052441
Device Name GE LOGIQ 7 ULTRASOUND BT05
Applicant
General Electric Co.
4855 W. Electric Ave.
P.O. Box 414
Milwaukee,  WI  53219
Applicant Contact ALLEN SCHUH
Correspondent
General Electric Co.
4855 W. Electric Ave.
P.O. Box 414
Milwaukee,  WI  53219
Correspondent Contact ALLEN SCHUH
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received09/06/2005
Decision Date 09/21/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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