FDA 510(k)

WRDensity by Whiterabbit.ai

Número K: K202013 · 2020-10-30

Data da decisão2020-10-30

Código do produtoQIH

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

WRDensity by Whiterabbit.ai is the device name listed in this FDA 510(k) record. The listed applicant is Whiterabbit.Ai, Inc.. It received FDA 510(k) clearance on 2020-10-30 under 510(k) number K202013. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the WRDensity by Whiterabbit.ai?

WRDensity by Whiterabbit.ai is a medical device that received FDA 510(k) clearance on 2020-10-30. The listed applicant is Whiterabbit.Ai, Inc.. The 510(k) number is K202013.

When did WRDensity by Whiterabbit.ai receive FDA 510(k) clearance?

WRDensity by Whiterabbit.ai received FDA 510(k) clearance on 2020-10-30, under 510(k) number K202013.

Who is the listed applicant for WRDensity by Whiterabbit.ai?

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

What is the FDA product code for WRDensity by Whiterabbit.ai?

The FDA product code for WRDensity by Whiterabbit.ai is QIH.

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