FDA 510(k)

Okti

K-Number: K230073 · 2023-02-09

Decision Date2023-02-09

Product CodeGWQ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Okti is the device name listed in this FDA 510(k) record. The listed applicant is Compumedics Limited. It received FDA 510(k) clearance on 2023-02-09 under 510(k) 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. The listed applicant is Compumedics Limited. The 510(k) number is K230073.

When did Okti receive FDA 510(k) clearance?

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

Who is the listed applicant for Okti?

The FDA 510(k) record lists Compumedics Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Okti?

The FDA product code for Okti is GWQ.

Other records listing Compumedics Limited as applicant

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.

K252383Somfit D K242447Falcon HST K231546Somfit K191785Orion LifeSpan MEG

Related Devices (Code: GWQ)

K261604Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)Neuroelectrics Barcelona S.L.U.K260455New Wave SystemZeto, Inc.K233403Flexset SystemZeto, Inc.K231366Neuronaute PlusBioserenity Sas K221959Q21Neurofield, Inc.K231457SPARK ScanSpark Neuro, Inc.

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.