K242528
- 510(k) number
- K242528
- Device name
- Blood Pressure Monitor (RAK260, RAK262, RAK263, RAK266, RAK268, RAK269, RAK282, RAK283, RAK286, RAK288, RAK289, RAK291, RAK292, RAK293, RAK295, RAK296, RAK297, RAK298)
- Applicant
- Shenzhen Ruiankang Technology Co., Ltd. CN
- Product code
- DXN — System, Measurement, Blood-Pressure, Non-Invasive
- Decision date
- 2025-01-10
- Date received
- 2024-08-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.8 MB · U.S. public domain
Also available from FDA: K242528.pdf
Official FDA record: K242528
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.