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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
Predetermined Change
Control Plan Authorized		 No
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