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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 Doppler, Ultrasonic
510(k) Number K872292
Device Name TRANSPECT TRANSCRANIAL DOPPLER
Applicant
Medasonics, Inc.
82 Pioneer Way
P.O. Box 7268
Mountain View,  CA  94042
Applicant Contact WILLIAM E MCKAY
Correspondent
Medasonics, Inc.
82 Pioneer Way
P.O. Box 7268
Mountain View,  CA  94042
Correspondent Contact WILLIAM E MCKAY
Regulation Number892.1550
Classification Product Code
IYN  
Date Received06/16/1987
Decision Date 08/14/1987
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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