FDA 510(k)

Intraosseous infusion device

N.º K: K191258 · 2019-10-23

Fecha de decisión2019-10-23

Código de productoFMI

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Intraosseous infusion device is the device name listed in this FDA 510(k) record. The listed applicant is Einstein Works, LLC. It received FDA 510(k) clearance on 2019-10-23 under 510(k) number K191258. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Intraosseous infusion device?

Intraosseous infusion device is a medical device that received FDA 510(k) clearance on 2019-10-23. The listed applicant is Einstein Works, LLC. The 510(k) number is K191258.

When did Intraosseous infusion device receive FDA 510(k) clearance?

Intraosseous infusion device received FDA 510(k) clearance on 2019-10-23, under 510(k) number K191258.

Who is the listed applicant for Intraosseous infusion device?

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

What is the FDA product code for Intraosseous infusion device?

The FDA product code for Intraosseous infusion device is FMI.

Ensayos clínicos relacionados

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Otros registros que enlistan a Einstein Works, LLC como solicitante

K211395NIO-I K182770Dispositivo de Infusión Intraóssea para Adultos

Dispositivos relacionados (Código: FMI)

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Fuente oficial

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