K233418
- 510(k) number
- K233418
- Device name
- Biofourmis Everion+ (G2)
- Applicant
- Biofourmis Singapore Pte., Ltd. SG
- Product code
- MSX — System, Network And Communication, Physiological Mon
- Decision date
- 2024-05-09
- Date received
- 2023-10-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K233418.pdf
Official FDA record: K233418
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.