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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 K182199
Device Name NFC-700 non-mydriatic auto fundus camera
Applicant
Crystalvue Medical Corporation
No.116, Ln.956, Zhongshan Rd., Taoyuan Dist.,
Taoyuan,  TW 33072
Applicant Contact Oliver Lin
Correspondent
Crystalvue Medical Corporation
No.116, Ln.956, Zhongshan Rd., Taoyuan Dist.,
Taoyuan,  TW 33072
Correspondent Contact Oliver Lin
Regulation Number886.1120
Classification Product Code
HKI  
Date Received08/14/2018
Decision Date 01/02/2019
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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