FDA 510(k)

Respiration Rate algorithm

Número K: K251326 · 2026-06-11

Data da decisão2026-06-11

Código do produtoBZQ

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Respiration Rate algorithm is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2026-06-11 under 510(k) number K251326. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Respiration Rate algorithm?

Respiration Rate algorithm is a medical device that received FDA 510(k) clearance on 2026-06-11. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K251326.

When did Respiration Rate algorithm receive FDA 510(k) clearance?

Respiration Rate algorithm received FDA 510(k) clearance on 2026-06-11, under 510(k) number K251326.

Who is the listed applicant for Respiration Rate algorithm?

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

What is the FDA product code for Respiration Rate algorithm?

The FDA product code for Respiration Rate algorithm is BZQ.

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Fonte oficial

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