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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Fetal Doppler Ultrasound
510(k) Number K905456
Device Name L328 TRANSDUCER
Applicant
Acuson Corp.
1220 Charleston Rd.
Mountain View,  CA  94039
Applicant Contact SHEILA W PICKERING
Correspondent
Acuson Corp.
1220 Charleston Rd.
Mountain View,  CA  94039
Correspondent Contact SHEILA W PICKERING
Regulation Number884.2660
Classification Product Code
MAA  
Date Received12/04/1990
Decision Date 05/28/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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