K242117
- 510(k) number
- K242117
- Device name
- LifeShield Infusion Safety Software Suite
- Applicant
- Icu Medical, Inc. IL · US
- Product code
- PHC — Infusion Safety Management Software
- Decision date
- 2025-04-02
- Date received
- 2024-07-19
- 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: K242117.pdf
Official FDA record: K242117
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.