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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
Applicant
GENERAL ELECTRIC CO.
p.o. box 414
milwaukee,  WI  53201
Applicant Contact allen schuh
Correspondent
GENERAL ELECTRIC CO.
p.o. box 414
milwaukee,  WI  53201
Correspodent 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 (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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