Elfor-L— 510(k) K243852
Substantially EquivalentElfi-Tech , Ltd.
FDA 510(k) clearance K243852 for Elfor-L, Substantially Equivalent on 2025-04-14. Applicant: Elfi-Tech , Ltd.. Device class: 2.
Clearance details
- Applicant
- Elfi-Tech , Ltd.
- Product code
- Code DPW
- Device class
- Class 2
- Regulation
- 21 CFR 870.2100
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tel Aviv, IL
Recent devices under product code DPW
view all- K260700 — BlueDop Vascular Expert
- K252810 — FloPatch FP120
- K251904 — VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01) +1 more
- K251114 — FloPatch FP120
- K241583 — VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01) +1 more
Data sourced from openFDA. This site is unofficial and independent of the FDA.