K251113
- 510(k) number
- K251113
- Device name
- iHealth Compare Wireless Blood Pressure Monitor(BP-300C);iHealth Compare Pro Wireless Blood Pressure Monitor(BP-300CV);iHealth Compare S Wireless Blood Pressure Monitor(BP-300V);iHealth Wireless Blood Pressure Monitor(BPX1);iHealth Blood Pressure Monitor(KD-595);iHealth Track Pro Connected Blood Pressure Monitor(KN-550LT);Semi Automatic Blood Pressure Monitor(KD-388N);Arm Blood Pressure Monitor(KD-553);Arm Blood Pressure Monitor(KD-557BR);Arm Blood Pressure Monitor(KD-558);Arm Blood Pr
- Applicant
- Andon Health Co, Ltd. CN
- Product code
- DXN — System, Measurement, Blood-Pressure, Non-Invasive
- Decision date
- 2025-08-04
- Date received
- 2025-04-11
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.6 MB · U.S. public domain
Also available from FDA: K251113.pdf
Official FDA record: K251113
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.