FDA 510(k)

Edema Guard Monitor (EGM) CardioSet-001

Номер K: K250922 · 2025-09-09

Дата решения2025-09-09

Код продуктаDSB

Консультативный комитетCV

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: DSB)

K260224MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)ImpediMed Limited K250634BCM2-Body Composition MonitorFresenius Medical Care Renal Therapies Group, LLC K243727Re:BalansMode Sensors AS K232089SOZO ProImpediMed Limited K223217Zynex Monitoring System, Model CM-1600Zynex Medical, Inc.K211585Bodyport Cardiac ScaleBodyport, Inc.

Официальный источник

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