K232365
- 510(k) number
- K232365
- Device name
- Vivo 45 LS
- Applicant
- Oconnell Regulatory Consultants, Inc. MA · US
- Product code
- CBK — Ventilator, Continuous, Facility Use
- Decision date
- 2025-12-19
- Date received
- 2023-08-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K232365.pdf
Official FDA record: K232365
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.