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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cranial Motion Measurement Device
510(k) Number K170926
Device Name BrainPulse 1100
Applicant
Jan Medical, Inc.
110 Pioneer Way, Suite L
Mountain View,  CA  94041
Applicant Contact Prabhu Raghavan
Correspondent
Jan Medical, Inc.
110 Pioneer Way, Suite L
Mountain View,  CA  94041
Correspondent Contact Prabhu Raghavan
Regulation Number882.1630
Classification Product Code
POP  
Date Received03/29/2017
Decision Date 04/28/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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