K250922
- 510(k) number
- K250922
- Device name
- Edema Guard Monitor (EGM) CardioSet-001
- Applicant
- Cardioset Medical , Ltd. IL
- Product code
- DSB — Plethysmograph, Impedance
- Decision date
- 2025-09-09
- Date received
- 2025-03-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K250922.pdf
Official FDA record: K250922
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.