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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 K041688
Device Name GE VOLUSON 730 PRO/EXPERT UNTRASOUND BT04
Applicant
GENERAL ELECTRIC CO.
4855 WESTELECTRIC AVENUE
PO BOX 414
MILWAUKEE,  WI  53219
Applicant Contact ALLEN SCHUH
Correspondent
GENERAL ELECTRIC CO.
4855 WESTELECTRIC AVENUE
PO BOX 414
MILWAUKEE,  WI  53219
Correspondent Contact ALLEN SCHUH
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received06/22/2004
Decision Date 07/08/2004
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
Recalls CDRH Recalls
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