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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, imaging, optical coherence tomography (oct)
510(k) Number K201552
Device Name ApolloVue S100 Image System
Apollo Medical Optics, Ltd.
2F., No.43, Ln. 188, Ruiguang Rd., Neihu Dist.
Taipei City,  TW 114
Applicant Contact Chi-Hua Wu
Elite BioMedical Consulting, Inc.
29122 Rancho Viejo Rd. Suite 212
San Juan Capistrano,  CA  92675
Correspondent Contact Feng-Yu Lee
Regulation Number892.1560
Classification Product Code
Date Received06/10/2020
Decision Date 09/02/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No