FDA 510(k)

Sight OLO

K-Number: K190898 · 2019-11-01

Decision Date2019-11-01

Product CodeGKZ

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

Sight OLO is the device name listed in this FDA 510(k) record. The listed applicant is Sight Diagnostics , Ltd.. It received FDA 510(k) clearance on 2019-11-01 under 510(k) 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. The listed applicant is Sight Diagnostics , Ltd.. The 510(k) number is K190898.

When did Sight OLO receive FDA 510(k) clearance?

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

Who is the listed applicant for Sight OLO?

The FDA 510(k) record lists Sight Diagnostics , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sight OLO?

The FDA product code for Sight OLO is GKZ.

Related Devices (Code: GKZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.