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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plethysmograph, Impedance
510(k) Number K250922
Device Name Edema Guard Monitor (EGM) CardioSet-001
Applicant
Cardioset Medical , Ltd.
Havazelet 26 St.
Matan,  IL 4585800
Applicant Contact Assaf Gur
Correspondent
Hogan Lovells Llp
555 13th St., NW
Washington,  DC  20004
Correspondent Contact John Smith
Regulation Number870.2770
Classification Product Code
DSB  
Date Received03/27/2025
Decision Date 09/09/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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