K243118
- 510(k) number
- K243118
- Device name
- Arm Blood Pressure Monitor (model: BPM-A7VL)
- Applicant
- Shenzhen Imdk Medical Technology Co., Ltd. CN
- Product code
- DXN — System, Measurement, Blood-Pressure, Non-Invasive
- Decision date
- 2024-11-26
- Date received
- 2024-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K243118.pdf
Official FDA record: K243118
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.