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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 K050326
Device Name 7350 ULTRASOUND IMAGING SYSTEM, MODEL 7350
Applicant
ESAOTE, S.P.A.
7992 CASTLEWAY DRIVE
INDIANAPOLIS,  IN  46250
Applicant Contact CARRI GRAHAM
Correspondent
ESAOTE, S.P.A.
7992 CASTLEWAY DRIVE
INDIANAPOLIS,  IN  46250
Correspondent Contact CARRI GRAHAM
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received02/09/2005
Decision Date 02/28/2005
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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