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FDA 510(k)

Clarius Median Nerve AI

K-Number: K250226 · 2025-05-08

ApplicantClarius Mobile Health Corp.
Decision Date2025-05-08
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Clarius Median Nerve AI is a medical device manufactured by Clarius Mobile Health Corp.. It received FDA 510(k) clearance on 2025-05-08 under approval number K250226. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Clarius Median Nerve AI?

Clarius Median Nerve AI is a medical device that received FDA 510(k) clearance on 2025-05-08. It is manufactured by Clarius Mobile Health Corp.. The 510(k) number is K250226.

When was Clarius Median Nerve AI approved by the FDA?

Clarius Median Nerve AI received FDA 510(k) clearance on 2025-05-08, under approval number K250226.

What company makes Clarius Median Nerve AI?

Clarius Median Nerve AI is manufactured by Clarius Mobile Health Corp..

What is the FDA product code for Clarius Median Nerve AI?

The FDA product code for Clarius Median Nerve AI is QIH.

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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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