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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 K993365
Device Name GE LOGIQ 700 WITH HARMONIC IMAGING MODIFICATION
Applicant
Ge Medical Systems, Inc.
P.O. Box 414
Milwaukee,  WI  53201
Applicant Contact ALLEN SCHUH
Correspondent
Ge Medical Systems, Inc.
P.O. Box 414
Milwaukee,  WI  53201
Correspondent Contact ALLEN SCHUH
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
IYN  
Date Received10/06/1999
Decision Date 11/05/1999
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
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