FDA 510(k)

Sistema PSI Archer

N.º K: K243509 · 2025-05-12

Solicitante3D-Side

Fecha de decisión2025-05-12

Código de productoQHE

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Archer PSI System is the device name listed in this FDA 510(k) record. The listed applicant is 3D-Side. It received FDA 510(k) clearance on 2025-05-12 under 510(k) number K243509. The device is classified under product code QHE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Archer PSI System?

Archer PSI System is a medical device that received FDA 510(k) clearance on 2025-05-12. The listed applicant is 3D-Side. The 510(k) number is K243509.

When did Archer PSI System receive FDA 510(k) clearance?

Archer PSI System received FDA 510(k) clearance on 2025-05-12, under 510(k) number K243509.

Who is the listed applicant for Archer PSI System?

The FDA 510(k) record lists 3D-Side as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Archer PSI System?

The FDA product code for Archer PSI System is QHE.

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Fuente oficial

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