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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
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