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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 Echo, Ultrasonic
510(k) Number K014206
Device Name LOGIQBOOK
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
Correspondent Contact ALLEN SCHUH
Regulation Number892.1560
Classification Product Code
IYO  
Date Received12/21/2001
Decision Date 01/16/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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