K251640
- 510(k) number
- K251640
- Device name
- SIGMA Spectrum Infusion Pump with Master Drug Library
- Applicant
- Baxter Healthcare Corporation IL · US
- Product code
- FRN — Pump, Infusion
- Decision date
- 2025-07-28
- Date received
- 2025-05-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K251640.pdf
Official FDA record: K251640
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.