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FDA 510(k)

Sight OLO

K-Number: K190898 · 2019-11-01

ApplicantSight Diagnostics , Ltd.
Decision Date2019-11-01
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

Sight OLO is a medical device manufactured by Sight Diagnostics , Ltd.. It received FDA 510(k) clearance on 2019-11-01 under approval number K190898. 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 2019-11-01. It is manufactured by Sight Diagnostics , Ltd.. The 510(k) number is K190898.

When was Sight OLO approved by the FDA?

Sight OLO received FDA 510(k) clearance on 2019-11-01, under approval number K190898.

What company makes Sight OLO?

Sight OLO is manufactured by 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

View on FDA Database →

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

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