K261394
- 510(k) number
- K261394
- Device name
- Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus)
- Applicant
- JOYTECH Healthcare Co., Ltd. CN
- Product code
- DXN — System, Measurement, Blood-Pressure, Non-Invasive
- Decision date
- 2026-08-26
- Date received
- 2026-04-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K261394.pdf
Official FDA record: K261394
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.