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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 K930964
Device Name ACUSON MODEL #29001 (DIAGNOSTIC ULTRASOUND DEVICE)
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 Number892.1560
Classification Product Code
IYO  
Date Received02/24/1993
Decision Date 10/26/1994
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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