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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Ophthalmic, Ac-Powered
510(k) Number K210197
Device Name NFC-600 Automated Portable Retinal Camera
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 Number886.1120
Classification Product Code
HKI  
Date Received01/25/2021
Decision Date 04/13/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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