K243661
- 510(k) number
- K243661
- Device name
- Electronic Blood Pressure Monitor
- Applicant
- Hetaida Technology Co., Ltd. CN
- Product code
- DXN — System, Measurement, Blood-Pressure, Non-Invasive
- Decision date
- 2025-02-07
- Date received
- 2024-11-27
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K243661.pdf
Official FDA record: K243661
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.