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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, No.7, R&D Rd. II
Hsinchu Science Park
Hsinchu,  TW 30076
Applicant Contact Yi-Ying Chen
Correspondent
Medimaging Integrated Solution Inc. (MiiS)
1F, No.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
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