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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 K020263
Device Name LOGIQ 3
Original Applicant
GENERAL ELECTRIC CO.
p.o. box 414
milwaukee,  WI  53201
Original Contact allen schuh
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Code
IYO  
Date Received01/25/2002
Decision Date 02/06/2002
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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