FDA 510(k)

Nihon Kohden NKV-550 Series Ventilator System

Número K: K181695 · 2018-12-07

Data da decisão2018-12-07

Código do produtoCBK

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do 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, Inc.. It received FDA 510(k) clearance on 2018-12-07 under 510(k) number K181695. 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 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 2018-12-07. The listed applicant is Nihon Kohden Orangemed, Inc.. The 510(k) number is K181695.

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 2018-12-07, under 510(k) number K181695.

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

The FDA 510(k) record lists Nihon Kohden Orangemed, Inc. 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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Outros registros que listam Nihon Kohden Orangemed, Inc. como candidato(a)

K222644Nihon Kohden NKV-440 Ventilator System K213521Nihon Kohden NKV-330 Ventilator System K192307Nihon Kohden NKV-550 Series Ventilator System

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Fonte oficial

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