K250116
- 510(k) number
- K250116
- Device name
- Arm Blood Pressure Monitor (ARM-30H); Arm Blood Pressure Monitor (ARM-30J); Arm Blood Pressure Monitor (ARM-30K); Arm Blood Pressure Monitor (ARM-90B)
- Applicant
- Shenzhen AOJ Medical Technology Co., Ltd. CN
- Product code
- DXN — System, Measurement, Blood-Pressure, Non-Invasive
- Decision date
- 2025-04-24
- Date received
- 2025-01-16
- 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: K250116.pdf
Official FDA record: K250116
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.