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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 K193319
Device Name XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System
Applicant
Vasoptic Medical, Inc.
1215 E. Fort Ave., Suite 304
Baltimore,  MD  21230
Applicant Contact Abhishek Rege
Correspondent
Vasoptic Medical, Inc.
1215 E. Fort Ave., Suite 304
Baltimore,  MD  21230
Correspondent Contact Abhishek Rege
Regulation Number886.1120
Classification Product Code
HKI  
Date Received12/02/2019
Decision Date 06/01/2020
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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