K230883
- 510(k) number
- K230883
- Device name
- VersaPump Infusion System
- Applicant
- Emed Technologies Corporation CA · US
- Product code
- PKP — Immunoglobulin G (Igg) Infusion System
- Decision date
- 2023-11-28
- Date received
- 2023-03-30
- 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: K230883.pdf
Official FDA record: K230883
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.