K240148
- 510(k) number
- K240148
- Device name
- SCIg60 Infusion System
- Applicant
- Emed Technologies Corporation CA · US
- Product code
- PKP — Immunoglobulin G (Igg) Infusion System
- Decision date
- 2024-02-16
- Date received
- 2024-01-19
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 4.2 MB · U.S. public domain
Also available from FDA: K240148.pdf
Official FDA record: K240148
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.