Edema Guard Monitor (EGM) CardioSet-001— 510(k) K250922
Substantially EquivalentCardioset Medical , Ltd.
FDA 510(k) clearance K250922 for Edema Guard Monitor (EGM) CardioSet-001, Substantially Equivalent on 2025-09-09. Applicant: Cardioset Medical , Ltd.. Device class: 2.
Clearance details
- Applicant
- Cardioset Medical , Ltd.
- Product code
- Code DSB
- Device class
- Class 2
- Regulation
- 21 CFR 870.2770
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Matan, IL
Recent devices under product code DSB
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