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FDA 510(k)

Okti

K-Number: K230073 · 2023-02-09

ApplicantCompumedics Limited
Decision Date2023-02-09
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Okti is a medical device manufactured by Compumedics Limited. It received FDA 510(k) clearance on 2023-02-09 under approval number K230073. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Okti?

Okti is a medical device that received FDA 510(k) clearance on 2023-02-09. It is manufactured by Compumedics Limited. The 510(k) number is K230073.

When was Okti approved by the FDA?

Okti received FDA 510(k) clearance on 2023-02-09, under approval number K230073.

What company makes Okti?

Okti is manufactured by Compumedics Limited.

What is the FDA product code for Okti?

The FDA product code for Okti is GWQ.

Other Devices by Compumedics Limited

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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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