FDA 510(k)

Masimo Rad-G with Temperature

Número K: K213676 · 2023-04-16

Data da decisão2023-04-16

Código do produtoDQA

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Masimo Rad-G with Temperature is the device name listed in this FDA 510(k) record. The listed applicant is Masimo Corporation. It received FDA 510(k) clearance on 2023-04-16 under 510(k) number K213676. 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 Masimo Rad-G with Temperature?

Masimo Rad-G with Temperature is a medical device that received FDA 510(k) clearance on 2023-04-16. The listed applicant is Masimo Corporation. The 510(k) number is K213676.

When did Masimo Rad-G with Temperature receive FDA 510(k) clearance?

Masimo Rad-G with Temperature received FDA 510(k) clearance on 2023-04-16, under 510(k) number K213676.

Who is the listed applicant for Masimo Rad-G with Temperature?

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 Masimo Rad-G with Temperature?

The FDA product code for Masimo Rad-G with Temperature is DQA.

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Fonte oficial

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