Edema Guard Monitor (EGM) CardioSet-001— 510(k) K250922

Substantially Equivalent

Cardioset Medical , Ltd.

FDA 510(k) clearance K250922 for Edema Guard Monitor (EGM) CardioSet-001, Substantially Equivalent on 2025-09-09. Applicant: Cardioset Medical , Ltd..

Clearance details

Applicant: Cardioset Medical , Ltd.
Product code: Code DSB
Advisory panel: Cardiovascular
Date received: 2025-03-27
Decision date: 2025-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Matan, IL

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