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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 K061755
Device Name MYLAB15/20 NEW INDICATIONS ULTRASOUND SYSTEM
Applicant
Esaote Europe B.V.
11460 N.Meridian St.,
Suite 150
Carmel,  IN  46032
Applicant Contact CARRI GRAHAM
Correspondent
Esaote Europe B.V.
11460 N.Meridian St.,
Suite 150
Carmel,  IN  46032
Correspondent Contact CARRI GRAHAM
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Codes
ITX   IYN  
Date Received06/21/2006
Decision Date 08/07/2006
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
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