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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 K883238
Device Name GENESIS II TRANSCRANIAL PROBE
Original Applicant
BIOSOUND, INC.
7990 castleway dr.
p.o. box 50867
indianapolis,  IN  46250
Original Contact robert courtney
Regulation Number892.1560
Classification Product Code
IYO  
Date Received08/01/1988
Decision Date 08/24/1988
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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