510(k) K250922
K250922 is an FDA 510(k) premarket notification submitted by Cardioset Medical , Ltd. for the device "Edema Guard Monitor (EGM) CardioSet-001". The FDA issued a decision of Substantially Equivalent on September 9, 2025. The device falls under product code DSB (Plethysmograph, Impedance), a Class II device regulated under 21 CFR 870.2770.
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