K242568
- 510(k) number
- K242568
- Device name
- Wrist Blood Pressure Monitor (OHMS11, OHMS12)
- Applicant
- Shenzhen Zhongkemingwang Telecommunications Software Corp. CN
- Product code
- DXN — System, Measurement, Blood-Pressure, Non-Invasive
- Decision date
- 2025-01-30
- Date received
- 2024-08-29
- 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: K242568.pdf
Official FDA record: K242568
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.