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FDA 510(k)

Echo-2

K-Number: K254240 · 2026-09-22

ApplicantNeko Health AB
Decision Date2026-09-22
Product CodeQOK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Echo-2 is the device name listed in this FDA 510(k) record. The listed applicant is Neko Health AB. It received FDA 510(k) clearance on 2026-09-22 under 510(k) number K254240. The device is classified under product code QOK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Echo-2?

Echo-2 is a medical device that received FDA 510(k) clearance on 2026-09-22. The listed applicant is Neko Health AB. The 510(k) number is K254240.

When did Echo-2 receive FDA 510(k) clearance?

Echo-2 received FDA 510(k) clearance on 2026-09-22, under 510(k) number K254240.

Who is the listed applicant for Echo-2?

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

What is the FDA product code for Echo-2?

The FDA product code for Echo-2 is QOK.

Other records listing Neko Health AB 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.

K254129Spectrum-2K253911Derma-2

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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