K243392
- 510(k) number
- K243392
- Device name
- Infusomat® Space Volumetric Infusion Pump Administration Sets
- Applicant
- B.Braun Medical, Inc. PA · US
- Product code
- FPA — Set, Administration, Intravascular
- Decision date
- 2025-07-24
- Date received
- 2024-10-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K243392.pdf
Official FDA record: K243392
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.