FDA 510(k)

Constellation (CON-001)

N.º K: K241280 · 2024-09-12

Fecha de decisión2024-09-12

Código de productoQIH

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

Constellation (CON-001) is the device name listed in this FDA 510(k) record. The listed applicant is Q Bio, Inc.. It received FDA 510(k) clearance on 2024-09-12 under 510(k) number K241280. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Constellation (CON-001)?

Constellation (CON-001) is a medical device that received FDA 510(k) clearance on 2024-09-12. The listed applicant is Q Bio, Inc.. The 510(k) number is K241280.

When did Constellation (CON-001) receive FDA 510(k) clearance?

Constellation (CON-001) received FDA 510(k) clearance on 2024-09-12, under 510(k) number K241280.

Who is the listed applicant for Constellation (CON-001)?

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

What is the FDA product code for Constellation (CON-001)?

The FDA product code for Constellation (CON-001) is QIH.

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Fuente oficial

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