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FDA 510(k)

Sight OLO

K-Number: K211840 · 2022-05-09

ApplicantS.D. Sight Diagnostics , Ltd.
Decision Date2022-05-09
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

Sight OLO is a medical device manufactured by S.D. Sight Diagnostics , Ltd.. It received FDA 510(k) clearance on 2022-05-09 under approval number K211840. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sight OLO?

Sight OLO is a medical device that received FDA 510(k) clearance on 2022-05-09. It is manufactured by S.D. Sight Diagnostics , Ltd.. The 510(k) number is K211840.

When was Sight OLO approved by the FDA?

Sight OLO received FDA 510(k) clearance on 2022-05-09, under approval number K211840.

What company makes Sight OLO?

Sight OLO is manufactured by S.D. Sight Diagnostics , Ltd..

What is the FDA product code for Sight OLO?

The FDA product code for Sight OLO is GKZ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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