FDA 510(k)

Infant Incubator

N.º K: K190494 · 2019-11-25

SolicitanteNingbo David Medical Device Co., Ltd.

Fecha de decisión2019-11-25

Código de productoFMZ

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Infant Incubator is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo David Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2019-11-25 under 510(k) number K190494. The device is classified under product code FMZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Infant Incubator?

Infant Incubator is a medical device that received FDA 510(k) clearance on 2019-11-25. The listed applicant is Ningbo David Medical Device Co., Ltd.. The 510(k) number is K190494.

When did Infant Incubator receive FDA 510(k) clearance?

Infant Incubator received FDA 510(k) clearance on 2019-11-25, under 510(k) number K190494.

Who is the listed applicant for Infant Incubator?

The FDA 510(k) record lists Ningbo David Medical Device Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Infant Incubator?

The FDA product code for Infant Incubator is FMZ.

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Fuente oficial

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