FDA 510(k)

Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue

Número K: K232389 · 2023-09-07

Data da decisão2023-09-07

Código do produtoDQA

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue is the device name listed in this FDA 510(k) record. The listed applicant is Masimo Corporation. It received FDA 510(k) clearance on 2023-09-07 under 510(k) number K232389. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue?

Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue is a medical device that received FDA 510(k) clearance on 2023-09-07. The listed applicant is Masimo Corporation. The 510(k) number is K232389.

When did Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue receive FDA 510(k) clearance?

Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue received FDA 510(k) clearance on 2023-09-07, under 510(k) number K232389.

Who is the listed applicant for Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue?

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

What is the FDA product code for Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue?

The FDA product code for Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue is DQA.

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Dispositivos Relacionados (Código: DQA)

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Fonte oficial

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