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FDA 510(k)

Wrist Blood Pressure Monitor, Blood Pressure Monitor

N.º K: K210768 · 2021-07-30

SolicitanteAndon Health Co, Ltd.
Fecha de decisión2021-07-30
Código de productoDXN
Comité asesorCV
DecisiónSubstantially Equivalent

Resumen del dispositivo

Wrist Blood Pressure Monitor, Blood Pressure Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Andon Health Co, Ltd.. It received FDA 510(k) clearance on 2021-07-30 under 510(k) number K210768. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Wrist Blood Pressure Monitor, Blood Pressure Monitor?

Wrist Blood Pressure Monitor, Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2021-07-30. The listed applicant is Andon Health Co, Ltd.. The 510(k) number is K210768.

When did Wrist Blood Pressure Monitor, Blood Pressure Monitor receive FDA 510(k) clearance?

Wrist Blood Pressure Monitor, Blood Pressure Monitor received FDA 510(k) clearance on 2021-07-30, under 510(k) number K210768.

Who is the listed applicant for Wrist Blood Pressure Monitor, Blood Pressure Monitor?

The FDA 510(k) record lists Andon Health Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Wrist Blood Pressure Monitor, Blood Pressure Monitor?

The FDA product code for Wrist Blood Pressure Monitor, Blood Pressure Monitor is DXN.

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Dispositivos relacionados (Código: DXN)

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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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