FDA 510(k)

X-PLO2R

Número K: K203086 · 2021-03-02

Data da decisão2021-03-02

Código do produtoCAW

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

X-PLO2R is the device name listed in this FDA 510(k) record. The listed applicant is Belluscura, LLC. It received FDA 510(k) clearance on 2021-03-02 under 510(k) number K203086. The device is classified under product code CAW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the X-PLO2R?

X-PLO2R is a medical device that received FDA 510(k) clearance on 2021-03-02. The listed applicant is Belluscura, LLC. The 510(k) number is K203086.

When did X-PLO2R receive FDA 510(k) clearance?

X-PLO2R received FDA 510(k) clearance on 2021-03-02, under 510(k) number K203086.

Who is the listed applicant for X-PLO2R?

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

What is the FDA product code for X-PLO2R?

The FDA product code for X-PLO2R is CAW.

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Fonte oficial

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