K251904
- 510(k) number
- K251904
- Device name
- VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01)
- Applicant
- Remington Medical, Inc. GA · US
- Product code
- DPW — Flowmeter, Blood, Cardiovascular
- Decision date
- 2025-11-20
- Date received
- 2025-06-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K251904.pdf
Official FDA record: K251904
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.