K241613
- 510(k) number
- K241613
- Device name
- Elecrtronic Blood Pressure Monitor (BP-201, BP-202, BP-203, BP-204, BP-205, BP-206)
- Applicant
- Shenzhen Hbcare Technology Co.,Ltd CN
- Product code
- DXN — System, Measurement, Blood-Pressure, Non-Invasive
- Decision date
- 2024-10-16
- Date received
- 2024-06-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K241613.pdf
Official FDA record: K241613
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.