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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Ophthalmic, Ac-Powered
510(k) Number K200254
Device Name Mydriatic Hyperspectral Retinal Camera (MHRC-C1)
Applicant
Optina Diagnostics
7405 Route Transcanadienne, Suite 300
Montreal,  CA H4T 1Z2
Applicant Contact Jean-Philippe Sylvestre
Correspondent
CardioMed Device Consultants, LLC
1783 Forest Dr. # 254
Annapolis,  MD  21401
Correspondent Contact Elisa Harvey
Regulation Number886.1120
Classification Product Code
HKI  
Subsequent Product Code
NFJ  
Date Received02/03/2020
Decision Date 04/27/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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