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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
Recalls CDRH Recalls
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