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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 K092271
FOIA Releasable 510(k) K092271
Device Name GE LOGIQ E9 BT2010 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 5205000-3, 5205000-4
Applicant
GE Healthcare
3000 N. Grandview Blvd. W-450
Waukesha,  WI  53188
Applicant Contact NICOLE LANDREVILLE
Correspondent
GE Healthcare
3000 N. Grandview Blvd. W-450
Waukesha,  WI  53188
Correspondent Contact NICOLE LANDREVILLE
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received07/28/2009
Decision Date 11/17/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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