Edema Guard Monitor (EGM) CardioSet-001
K-Number: K250922 · 2025-09-09
ApplicantCardioset Medical , Ltd.
Decision Date2025-09-09
Product CodeDSB
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Edema Guard Monitor (EGM) CardioSet-001 is a medical device manufactured by Cardioset Medical , Ltd.. It received FDA 510(k) clearance on 2025-09-09 under approval number K250922. The device is classified under product code DSB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
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. It is manufactured by Cardioset Medical , Ltd.. The 510(k) number is K250922.
When was Edema Guard Monitor (EGM) CardioSet-001 approved by the FDA?
Edema Guard Monitor (EGM) CardioSet-001 received FDA 510(k) clearance on 2025-09-09, under approval number K250922.
What company makes Edema Guard Monitor (EGM) CardioSet-001?
Edema Guard Monitor (EGM) CardioSet-001 is manufactured by Cardioset Medical , Ltd..
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.
Related Clinical Trials
Related Devices (Code: DSB)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.