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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic, Diagnostic
510(k) Number K904901
Device Name L11, L12 LINEAR AND C11, C12 CONVEX ARRAY TRANSDUC
Applicant
Parexel Intl. Corp.
One Alewife Pl.
Cambridge,  MS  02140
Applicant Contact BARRY SALL
Correspondent
Parexel Intl. Corp.
One Alewife Pl.
Cambridge,  MS  02140
Correspondent Contact BARRY SALL
Regulation Number892.1570
Classification Product Code
ITX  
Date Received10/30/1990
Decision Date 03/26/1991
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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