ApolloVue S100 Image System— 510(k) K201552

Name: FDA 510(k) clearance K201552
Creator: U.S. Food and Drug Administration
Published: 2020-09-02

Substantially Equivalent

Apollo Medical Optics, Ltd.

FDA 510(k) clearance K201552 for ApolloVue S100 Image System, Substantially Equivalent on 2020-09-02. Applicant: Apollo Medical Optics, Ltd.. Device class: 2.

Clearance details

Applicant: Apollo Medical Optics, Ltd.
Product code: Code NQQ
Device class: Class 2
Regulation: 21 CFR 892.1560
Advisory panel: Radiology
Date received: 2020-06-10
Decision date: 2020-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei City, TW

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.