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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 K180820
Device Name Tono Vue Non-Contact Tonometer
Applicant
Crystalvue Medical Corporation
# 116, Ln.956, Zhongshan Rd., Taoyuan Dist.,
Taoyuan City,  TW 33072
Applicant Contact Oliver Lin
Correspondent
Crystalvue Medical Corporation
# 116, Ln.956, Zhongshan Rd., Taoyuan Dist.,
Taoyuan City,  TW 33072
Correspondent Contact Oliver Lin
Regulation Number886.1930
Classification Product Code
HKX  
Date Received03/29/2018
Decision Date 12/14/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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