K243855
- 510(k) number
- K243855
- Device name
- BD Alaris Infusion System with Guardrails Suite MX
- Applicant
- Carefusion 303, Inc. CA · US
- Product code
- FRN — Pump, Infusion
- Decision date
- 2025-04-25
- Date received
- 2024-12-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K243855.pdf
Official FDA record: K243855
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.