K232451
- 510(k) number
- K232451
- Device name
- Insulia Bolus Companion
- Applicant
- Voluntis Sa. FR
- Product code
- NDC — Calculator, Drug Dose
- Decision date
- 2023-12-12
- Date received
- 2023-08-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K232451.pdf
Official FDA record: K232451
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.