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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 K181260
Device Name MiiS Horus Scope DPT 100
Applicant
Medimaging Integrated Solution Inc. (MiiS)
1F, No.7, R&D Rd. II
Hsinchu Science Park
Hsinchu,  CN 30076
Applicant Contact Chih-Lu Hsu
Correspondent
Medimaging Integrated Solution Inc. (MiiS)
1F, No.7, R&D Rd. II
Hsinchu Science Park
Hsinchu,  CN 30076
Correspondent Contact Chih-Lu Hsu
Regulation Number886.1930
Classification Product Code
HKX  
Date Received05/11/2018
Decision Date 06/21/2019
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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