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FDA 510(k)

ApolloVue S100 Image System

K-Number: K201552 · 2020-09-02

ApplicantApollo Medical Optics, Ltd.
Decision Date2020-09-02
Product CodeNQQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ApolloVue S100 Image System is a medical device manufactured by Apollo Medical Optics, Ltd.. It received FDA 510(k) clearance on 2020-09-02 under approval number K201552. The device is classified under product code NQQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ApolloVue S100 Image System?

ApolloVue S100 Image System is a medical device that received FDA 510(k) clearance on 2020-09-02. It is manufactured by Apollo Medical Optics, Ltd.. The 510(k) number is K201552.

When was ApolloVue S100 Image System approved by the FDA?

ApolloVue S100 Image System received FDA 510(k) clearance on 2020-09-02, under approval number K201552.

What company makes ApolloVue S100 Image System?

ApolloVue S100 Image System is manufactured by Apollo Medical Optics, Ltd..

What is the FDA product code for ApolloVue S100 Image System?

The FDA product code for ApolloVue S100 Image System is NQQ.

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Official Source

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