FDA 510(k)

Panther 5

Número K: K213098 · 2023-07-20

Data da decisão2023-07-20

Código do produtoCBK

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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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