ApolloVue S100 Image System

System, Imaging, Optical Coherence Tomography (oct)

Apollo Medical Optics, Ltd.

The following data is part of a premarket notification filed by Apollo Medical Optics, Ltd. with the FDA for Apollovue S100 Image System.

Pre-market Notification Details

Device IDK201552
510k NumberK201552
Device Name:ApolloVue S100 Image System
ClassificationSystem, Imaging, Optical Coherence Tomography (oct)
Applicant Apollo Medical Optics, Ltd. 2F., No.43, Ln. 188, Ruiguang Rd., Neihu Dist. Taipei City,  TW 114
ContactChi-hua Wu
CorrespondentFeng-yu Lee
Elite BioMedical Consulting, Inc. 29122 Rancho Viejo Rd. Suite 212 San Juan Capistrano,  CA  92675
Product CodeNQQ  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-10
Decision Date2020-09-02

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