Class Class II

Edema Guard Monitor (EGM) CardioSet-001 (K250922)

K250922 2025-09-09 Traditional
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Description

Edema Guard Monitor (EGM) CardioSet-001 by Cardioset Medical , Ltd., an FDA 510(k) cleared cardiovascular device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK250922
Clearance Date2025-09-09
Clearance TypeTraditional
Product CodeDSB
Regulation Number870.2770

Categories

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