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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name nystagmograph
510(k) Number K181771
Device Name RightEye Vision System
Applicant
RightEye, LLC
7979 Old Georgetown Rd., Suite 801
Bethesda,  MD  20814
Applicant Contact Adam Gross
Correspondent
RightEye, LLC
7979 Old Georgetown Rd., Suite 801
Bethesda,  MD  20814
Correspondent Contact Adam Gross
Regulation Number882.1460
Classification Product Code
GWN  
Date Received07/03/2018
Decision Date 09/28/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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