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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 K082185
FOIA Releasable 510(k) K082185
Device Name GE LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS 5205000, 5205000-2
Applicant
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA
9900 INNOVATION DR.
WAUWATOSA,  WI  53226
Applicant Contact NICOLE LANDREVILLE
Correspondent
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA
9900 INNOVATION DR.
WAUWATOSA,  WI  53226
Correspondent Contact NICOLE LANDREVILLE
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
IYN  
Date Received08/01/2008
Decision Date 08/15/2008
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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