FDA 510(k)

Biomonitor III, Biomonitor IIIm

N.º K: K201865 · 2020-12-08

Fecha de decisión2020-12-08

Código de productoMXD

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Biomonitor III, Biomonitor IIIm is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, Inc.. It received FDA 510(k) clearance on 2020-12-08 under 510(k) number K201865. The device is classified under product code MXD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Biomonitor III, Biomonitor IIIm?

Biomonitor III, Biomonitor IIIm is a medical device that received FDA 510(k) clearance on 2020-12-08. The listed applicant is Biotronik, Inc.. The 510(k) number is K201865.

When did Biomonitor III, Biomonitor IIIm receive FDA 510(k) clearance?

Biomonitor III, Biomonitor IIIm received FDA 510(k) clearance on 2020-12-08, under 510(k) number K201865.

Who is the listed applicant for Biomonitor III, Biomonitor IIIm?

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

What is the FDA product code for Biomonitor III, Biomonitor IIIm?

The FDA product code for Biomonitor III, Biomonitor IIIm is MXD.

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Dispositivos relacionados (Código: MXD)

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Fuente oficial

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