FDA 510(k)

Edema Guard Monitor (EGM) CardioSet-001

Número K: K250922 · 2025-09-09

Data da decisão2025-09-09

Código do produtoDSB

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Edema Guard Monitor (EGM) CardioSet-001 is the device name listed in this FDA 510(k) record. The listed applicant is Cardioset Medical , Ltd.. It received FDA 510(k) clearance on 2025-09-09 under 510(k) number K250922. The device is classified under product code DSB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Edema Guard Monitor (EGM) CardioSet-001?

Edema Guard Monitor (EGM) CardioSet-001 is a medical device that received FDA 510(k) clearance on 2025-09-09. The listed applicant is Cardioset Medical , Ltd.. The 510(k) number is K250922.

When did Edema Guard Monitor (EGM) CardioSet-001 receive FDA 510(k) clearance?

Edema Guard Monitor (EGM) CardioSet-001 received FDA 510(k) clearance on 2025-09-09, under 510(k) number K250922.

Who is the listed applicant for Edema Guard Monitor (EGM) CardioSet-001?

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

What is the FDA product code for Edema Guard Monitor (EGM) CardioSet-001?

The FDA product code for Edema Guard Monitor (EGM) CardioSet-001 is DSB.

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