K250091
- 510(k) number
- K250091
- Device name
- KOROT Blood Pressure Monitor (KOROT P3 Accurate)
- Applicant
- Korot Co., Ltd. KR
- Product code
- DXN — System, Measurement, Blood-Pressure, Non-Invasive
- Decision date
- 2025-03-14
- Date received
- 2025-01-14
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Flag
- Third-party review
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K250091.pdf
Official FDA record: K250091
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.