FDA 510(k)

RED

N.º K: K242304 · 2024-12-06

Fecha de decisión2024-12-06

Código de productoKLA

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

RED is the device name listed in this FDA 510(k) record. The listed applicant is Neuraxis, Inc.. It received FDA 510(k) clearance on 2024-12-06 under 510(k) number K242304. The device is classified under product code KLA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the RED?

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

When did RED receive FDA 510(k) clearance?

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

Who is the listed applicant for RED?

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

What is the FDA product code for RED?

The FDA product code for RED is KLA.

Literatura relacionada en PubMed

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Fuente oficial

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