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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 K973079
Device Name L7 TRANSDUCER USED ON ASPEN MODEL ULTRASOUND SYSTEM
Applicant
Acuson Corp.
1220 Charleston Rd.
Mountain View,  CA  94039
Applicant Contact WILLIAM WELCH
Correspondent
Acuson Corp.
1220 Charleston Rd.
Mountain View,  CA  94039
Correspondent Contact WILLIAM WELCH
Regulation Number892.1570
Classification Product Code
ITX  
Subsequent Product Code
IYN  
Date Received08/18/1997
Decision Date 11/05/1997
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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