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FDA 510(k)

Panther 5

N.º K: K213098 · 2023-07-20

SolicitanteOrigin Medical Devices
Fecha de decisión2023-07-20
Código de productoCBK
Comité asesorAN
DecisiónSubstantially Equivalent

Resumen del dispositivo

Panther 5 is the device name listed in this FDA 510(k) record. The listed applicant is Origin Medical Devices. It received FDA 510(k) clearance on 2023-07-20 under 510(k) number K213098. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Panther 5?

Panther 5 is a medical device that received FDA 510(k) clearance on 2023-07-20. The listed applicant is Origin Medical Devices. The 510(k) number is K213098.

When did Panther 5 receive FDA 510(k) clearance?

Panther 5 received FDA 510(k) clearance on 2023-07-20, under 510(k) number K213098.

Who is the listed applicant for Panther 5?

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

What is the FDA product code for Panther 5?

The FDA product code for Panther 5 is CBK.

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Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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