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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 K211355
Device Name iCare HOME2
Icare Finland Oy
Ayritie 22
Vantaa,  FI 01510
Applicant Contact Hannes Hyvönen
Icare Finland Oy
Ayritie 22
Vantaa,  FI 01510
Correspondent Contact Hannes Hyvönen
Regulation Number886.1930
Classification Product Code
Date Received05/03/2021
Decision Date 01/25/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No