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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 K032656
Device Name GE LOGIQ 9 ULTRASOUND BT03/IQ, MODEL 2375600-X
Applicant
Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc
4855 W. Electric Ave.
Milwaukee,  WI  53219
Applicant Contact ALLEN SCHUH
Correspondent
Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc
4855 W. Electric Ave.
Milwaukee,  WI  53219
Correspondent Contact ALLEN SCHUH
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received08/28/2003
Decision Date 10/30/2003
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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