K231586
- 510(k) number
- K231586
- Device name
- Endophys Blood Pressure Monitor model BPM-30
- Applicant
- Endophys Technologies, LLC TX · US
- Product code
- DSK — Computer, Blood-Pressure
- Decision date
- 2023-11-03
- Date received
- 2023-05-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K231586.pdf
Official FDA record: K231586
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.