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FDA 510(k)

Neu Platform

K-Number: K250153 · 2025-04-25

ApplicantNeuhealth Digital , Ltd.
Decision Date2025-04-25
Product CodeGYD
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Neu Platform is a medical device manufactured by Neuhealth Digital , Ltd.. It received FDA 510(k) clearance on 2025-04-25 under approval number K250153. The device is classified under product code GYD. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Neu Platform?

Neu Platform is a medical device that received FDA 510(k) clearance on 2025-04-25. It is manufactured by Neuhealth Digital , Ltd.. The 510(k) number is K250153.

When was Neu Platform approved by the FDA?

Neu Platform received FDA 510(k) clearance on 2025-04-25, under approval number K250153.

What company makes Neu Platform?

Neu Platform is manufactured by Neuhealth Digital , Ltd..

What is the FDA product code for Neu Platform?

The FDA product code for Neu Platform is GYD.

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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.

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