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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 K933663
Device Name MODIFICATION OF ACUSON V510B TRANSDUCER
Applicant
Acuson Corp.
1220 Charleston Rd.
Mountain View,  CA  94039
Applicant Contact SHEILA PICKERING
Correspondent
Acuson Corp.
1220 Charleston Rd.
Mountain View,  CA  94039
Correspondent Contact SHEILA PICKERING
Regulation Number892.1570
Classification Product Code
ITX  
Date Received07/28/1993
Decision Date 01/21/1994
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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