FDA 510(k)

Tempus Pro Patient Monitor

Número K: K201746 · 2020-09-18

RequerenteRemote Diagnostic Technologies Limited

Data da decisão2020-09-18

Código do produtoMHX

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Tempus Pro Patient Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Remote Diagnostic Technologies Limited. It received FDA 510(k) clearance on 2020-09-18 under 510(k) number K201746. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Tempus Pro Patient Monitor?

Tempus Pro Patient Monitor is a medical device that received FDA 510(k) clearance on 2020-09-18. The listed applicant is Remote Diagnostic Technologies Limited. The 510(k) number is K201746.

When did Tempus Pro Patient Monitor receive FDA 510(k) clearance?

Tempus Pro Patient Monitor received FDA 510(k) clearance on 2020-09-18, under 510(k) number K201746.

Who is the listed applicant for Tempus Pro Patient Monitor?

The FDA 510(k) record lists Remote Diagnostic Technologies Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tempus Pro Patient Monitor?

The FDA product code for Tempus Pro Patient Monitor is MHX.

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