FDA 510(k)

Surgify Halo

N.º K: K232684 · 2023-11-29

Fecha de decisión2023-11-29

Código de productoHBE

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Surgify Halo is the device name listed in this FDA 510(k) record. The listed applicant is Surgify Medical OY. It received FDA 510(k) clearance on 2023-11-29 under 510(k) number K232684. The device is classified under product code HBE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Surgify Halo?

Surgify Halo is a medical device that received FDA 510(k) clearance on 2023-11-29. The listed applicant is Surgify Medical OY. The 510(k) number is K232684.

When did Surgify Halo receive FDA 510(k) clearance?

Surgify Halo received FDA 510(k) clearance on 2023-11-29, under 510(k) number K232684.

Who is the listed applicant for Surgify Halo?

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

What is the FDA product code for Surgify Halo?

The FDA product code for Surgify Halo is HBE.

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Otros registros que enlistan a Surgify Medical OY como solicitante

Dispositivos relacionados (Código: HBE)

Fuente oficial

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