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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biomicroscope, Slit-Lamp, Ac-Powered
510(k) Number K170470
Device Name Digital Eye Anterior Camera
Applicant
Medimaging Integrated Solution, Inc (Miis)
1f, #7, R&D Rd. Ii
Hsinchu Science Park
Hsinchu,  TW 30076
Applicant Contact Yi-Ying Chen
Correspondent
Medimaging Integrated Solution, Inc (Miis)
1f, #7, R&D Rd. Ii
Hsinchu Science Park
Hsinchu,  TW 30076
Correspondent Contact Yi-Ying Chen
Regulation Number886.1850
Classification Product Code
HJO  
Subsequent Product Code
HKI  
Date Received02/16/2017
Decision Date 10/06/2017
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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