FDA 510(k)

TrueView 100 Pro

Número K: K202713 · 2020-11-18

RequerenteCompai Healthcare (Shenzhen) Co.,Ltd

Data da decisão2020-11-18

Código do produtoMWP

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

TrueView 100 Pro is the device name listed in this FDA 510(k) record. The listed applicant is Compai Healthcare (Shenzhen) Co.,Ltd. It received FDA 510(k) clearance on 2020-11-18 under 510(k) number K202713. The device is classified under product code MWP. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the TrueView 100 Pro?

TrueView 100 Pro is a medical device that received FDA 510(k) clearance on 2020-11-18. The listed applicant is Compai Healthcare (Shenzhen) Co.,Ltd. The 510(k) number is K202713.

When did TrueView 100 Pro receive FDA 510(k) clearance?

TrueView 100 Pro received FDA 510(k) clearance on 2020-11-18, under 510(k) number K202713.

Who is the listed applicant for TrueView 100 Pro?

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

What is the FDA product code for TrueView 100 Pro?

The FDA product code for TrueView 100 Pro is MWP.

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