K232328
- 510(k) number
- K232328
- Device name
- Insignis Syringe Infusion System
- Applicant
- Innovative Health Sciences, LLC NY · US
- Product code
- FPA — Set, Administration, Intravascular
- Decision date
- 2024-03-01
- Date received
- 2023-08-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K232328.pdf
Official FDA record: K232328
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.