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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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