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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tonometer, Ac-Powered
510(k) Number K190382
Device Name Intraocular Pressure Tonometer EASYTON
Applicant
Company Elamed
Yelatma instrument-making enterprise, JSC
391351, 25 Janina st.,
Yelatma,  RU
Applicant Contact Mikhail Kuzin
Correspondent
Company Elamed
Yelatma instrument-making enterprise, JSC
391351, 25 Janina st.,
Yelatma,  RU
Correspondent Contact Mikhail Kuzin
Regulation Number886.1930
Classification Product Code
HKX  
Date Received02/19/2019
Decision Date 12/06/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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