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510(k) K250922

Edema Guard Monitor (EGM) CardioSet-001 by Cardioset Medical , Ltd. — Product Code DSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 2025
Date Received
March 27, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plethysmograph, Impedance
Device Class
Class II
Regulation Number
870.2770
Review Panel
CV
Submission Type

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