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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 K073408
Device Name GE LOGIQ BT08 DIAGNOSTIC ULTRASOUND SYSTEM
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 Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received12/04/2007
Decision Date 12/19/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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