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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, mechanical, evoked response
510(k) Number K191700
Device Name EyeStat
Applicant
Blinktbi Inc.
635 Rutledge Ave., Suite 102
Charleston,  SC  29403
Applicant Contact Ryan Fiorini
Correspondent
S Mathur
635 Rutledge Ave, Suite 102
Charleston,  SC  29403
Correspondent Contact S. Mathur
Regulation Number882.1880
Classification Product Code
GZP  
Date Received06/25/2019
Decision Date 12/09/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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