K234041
- 510(k) number
- K234041
- Device name
- Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5811BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5810VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5810BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5920VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5920BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5923TS)
- Applicant
- Andon Health Co, Ltd. CN
- Product code
- DXN — System, Measurement, Blood-Pressure, Non-Invasive
- Decision date
- 2024-04-22
- Date received
- 2023-12-21
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.6 MB · U.S. public domain
Also available from FDA: K234041.pdf
Official FDA record: K234041
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.