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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 K050126
Device Name GE LOGIQ TWIN
Applicant
GENERAL ELECTRIC CO.
4855 west electric avenue
po box 414
milwaukee,  WI  53201
Applicant Contact allen schuh
Correspondent
GENERAL ELECTRIC CO.
4855 west electric avenue
po box 414
milwaukee,  WI  53201
Correspondent Contact allen schuh
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received01/19/2005
Decision Date 02/02/2005
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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