FDA 510(k)

Galaxy System

N.º K: K223144 · 2023-03-01

Fecha de decisión2023-03-01

Código de productoEOQ

Comité asesorEN

DecisiónSubstantially Equivalent

Resumen del dispositivo

Galaxy System is the device name listed in this FDA 510(k) record. The listed applicant is Noah Medical Corp.. It received FDA 510(k) clearance on 2023-03-01 under 510(k) number K223144. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Galaxy System?

Galaxy System is a medical device that received FDA 510(k) clearance on 2023-03-01. The listed applicant is Noah Medical Corp.. The 510(k) number is K223144.

When did Galaxy System receive FDA 510(k) clearance?

Galaxy System received FDA 510(k) clearance on 2023-03-01, under 510(k) number K223144.

Who is the listed applicant for Galaxy System?

The FDA 510(k) record lists Noah Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Galaxy System?

The FDA product code for Galaxy System is EOQ.

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Fuente oficial

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