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v3.0/ 2020-11-10
Tilak Healthcare SAS

74 rue du Faubourg Saint-Antoine
75012, PARIS, France
Tel : +33 (0)7 64 67 29 52
Fax : +33 (0)1 49 23 01 16
http://www.tilakhealthcare.com/
OdySight is a medical device according to European Directive 93/42/EEC.

"Rx only" OdySight is software as a medical device (SaMD) that is 510(k) exempted according to FDA Enforcement Policy for Remote Ophthalmic Assessmentand Monitoring Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency, April 2020)
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