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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 K992208
Device Name GE LOGIQ 200 MD DIAGNOSTIC ULTRASOUND SYSTEM
Applicant
GE MEDICAL SYSTEMS, INC.
P.O. BOX 414
MILWAUKEE,  WI  53201
Applicant Contact ALLEN SCHUH
Correspondent
UNDERWRITERS LABORATORIES, INC.
333 PFINGSTEN RD.
NORTHBROOK,  IL  60062
Correspondent Contact CHANTEL CARSON
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received06/30/1999
Decision Date 07/12/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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