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FDA 510(k)

Nihon Kohden NKV-550 Series Ventilator System

N.º K: K231778 · 2024-03-01

SolicitanteNihon Kohden Orangemed, LLC
Fecha de decisión2024-03-01
Código de productoCBK
Comité asesorAN
DecisiónSubstantially Equivalent

Resumen del dispositivo

Nihon Kohden NKV-550 Series Ventilator System is the device name listed in this FDA 510(k) record. The listed applicant is Nihon Kohden Orangemed, LLC. It received FDA 510(k) clearance on 2024-03-01 under 510(k) number K231778. 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 Nihon Kohden NKV-550 Series Ventilator System?

Nihon Kohden NKV-550 Series Ventilator System is a medical device that received FDA 510(k) clearance on 2024-03-01. The listed applicant is Nihon Kohden Orangemed, LLC. The 510(k) number is K231778.

When did Nihon Kohden NKV-550 Series Ventilator System receive FDA 510(k) clearance?

Nihon Kohden NKV-550 Series Ventilator System received FDA 510(k) clearance on 2024-03-01, under 510(k) number K231778.

Who is the listed applicant for Nihon Kohden NKV-550 Series Ventilator System?

The FDA 510(k) record lists Nihon Kohden Orangemed, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nihon Kohden NKV-550 Series Ventilator System?

The FDA product code for Nihon Kohden NKV-550 Series Ventilator System is CBK.

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Dispositivos relacionados (Código: 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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