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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 K183059
Device Name 3nethra neo
Applicant
Forus Health Pvt.Ltd
#86/2, Ground Floor, Dvg Smaraka Bhavana, Bull Temple Rd.
5th Main Nr Colony
Bengaluru,  IN 560019
Applicant Contact Shruti Kashinath
Correspondent
Forus Health Pvt.Ltd
#86/2, Ground Floor, Dvg Smaraka Bhavana, Bull Temple Rd.
5th Main Nr Colony
Bengaluru,  IN 560019
Correspondent Contact Shruti Kashinath
Regulation Number886.1120
Classification Product Code
HKI  
Date Received11/02/2018
Decision Date 12/21/2018
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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