K232053
- 510(k) number
- K232053
- Device name
- SimpleSense-BP, SimpleSense-BP Software Application
- Applicant
- Nanowear, Inc. NY · US
- Product code
- DXN — System, Measurement, Blood-Pressure, Non-Invasive
- Decision date
- 2023-12-08
- Date received
- 2023-07-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K232053.pdf
Official FDA record: K232053
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.