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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name tonometer, manual
510(k) Number K200966
Device Name Icare HOME Tonometer
Applicant
Icare Finland Oy
Ayritie 22
vantaa,  FI 01510
Applicant Contact hannes hyvonen
Correspondent
Icare Finland Oy
Ayritie 22
vantaa,  FI 01510
Correspondent Contact hannes hyvonen
Regulation Number886.1930
Classification Product Code
HKY  
Date Received04/10/2020
Decision Date 05/07/2020
Decision substantially equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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