K232495
- 510(k) number
- K232495
- Device name
- Sempulse Halo Vital Signs Monitor
- Applicant
- Sempulse Corporation TX · US
- Product code
- DQA — Oximeter
- Decision date
- 2024-05-16
- Date received
- 2023-08-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K232495
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.