MiiS Horus Eye Anterior Camera

Biomicroscope, Slit-lamp, Ac-powered

Medimaging Integrated Solution Inc. (MiiS)

The following data is part of a premarket notification filed by Medimaging Integrated Solution Inc. (miis) with the FDA for Miis Horus Eye Anterior Camera.

Pre-market Notification Details

Device IDK193188
510k NumberK193188
Device Name:MiiS Horus Eye Anterior Camera
ClassificationBiomicroscope, Slit-lamp, Ac-powered
Applicant Medimaging Integrated Solution Inc. (MiiS) 3F.,No.24-2, Industry E. Rd. IV, Hsinchu Science Park Hsinchu,  CN 30077
ContactYi-ying Chen
CorrespondentYi-ying Chen
Medimaging Integrated Solution Inc. (MiiS) 3F.,No.24-2, Industry E. Rd. IV, Hsinchu Science Park Hsinchu,  CN 30077
Product CodeHJO  
CFR Regulation Number886.1850 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOphthalmic
510k Review PanelOphthalmic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-18
Decision Date2020-01-14

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