K232713
- 510(k) number
- K232713
- Device name
- Blood Pressure Monitor
- Applicant
- Guangdong Transtek Medical Electronics Co., Ltd. CN
- Product code
- DXN — System, Measurement, Blood-Pressure, Non-Invasive
- Decision date
- 2023-11-28
- Date received
- 2023-09-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain
Also available from FDA: K232713.pdf
Official FDA record: K232713
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.