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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 K852974
Device Name ACUSON RADIOLOGY DOPPLER ACCESSORY
Applicant
Acuson Computed Sonography
1393 Shorebird Way
Mountain View,  CA  94043
Applicant Contact ROBERT J GALLAGHER
Correspondent
Acuson Computed Sonography
1393 Shorebird Way
Mountain View,  CA  94043
Correspondent Contact ROBERT J GALLAGHER
Regulation Number892.1570
Classification Product Code
ITX  
Date Received07/15/1985
Decision Date 10/24/1985
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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