K241634
- 510(k) number
- K241634
- Device name
- Wrist Blood Pressure Monitor (XY-W01A, XY-W01B)
- Applicant
- Guangdong Xinyu Electronic and Technology Co., Ltd. CN
- Product code
- DXN — System, Measurement, Blood-Pressure, Non-Invasive
- Decision date
- 2025-02-11
- Date received
- 2024-06-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K241634.pdf
Official FDA record: K241634
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.