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FDA 510(k)

RED

K-Number: K242304 · 2024-12-06

ApplicantNeuraxis, Inc.
Decision Date2024-12-06
Product CodeKLA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RED is a medical device manufactured by Neuraxis, Inc.. It received FDA 510(k) clearance on 2024-12-06 under approval number K242304. The device is classified under product code KLA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RED?

RED is a medical device that received FDA 510(k) clearance on 2024-12-06. It is manufactured by Neuraxis, Inc.. The 510(k) number is K242304.

When was RED approved by the FDA?

RED received FDA 510(k) clearance on 2024-12-06, under approval number K242304.

What company makes RED?

RED is manufactured by Neuraxis, Inc..

What is the FDA product code for RED?

The FDA product code for RED is KLA.

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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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