K240102
- 510(k) number
- K240102
- Device name
- Blood Pressure Monitor (TMB-2287-B)
- Applicant
- Guangdong Transtek Medical Electronics Co., Ltd. CN
- Product code
- DXN — System, Measurement, Blood-Pressure, Non-Invasive
- Decision date
- 2024-04-29
- Date received
- 2024-01-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K240102.pdf
Official FDA record: K240102
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.