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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 K896356
Device Name AU530 DIAGNOSTIC ULTRASONIC PULSED ECHO SYSTEM
Applicant
Esaote Biomedica Spa
C/O Parexel International Corp
One Alewife Pl.
Cambridge,  MA  02140
Applicant Contact SAYIGH, PHD
Correspondent
Esaote Biomedica Spa
C/O Parexel International Corp
One Alewife Pl.
Cambridge,  MA  02140
Correspondent Contact SAYIGH, PHD
Regulation Number892.1560
Classification Product Code
IYO  
Date Received11/06/1989
Decision Date 08/21/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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