K240915
- 510(k) number
- K240915
- Device name
- ZIEN IO Intraosseous Access System
- Applicant
- Zien Medical Technologies, Inc. UT · US
- Product code
- FMI — Needle, Hypodermic, Single Lumen
- Decision date
- 2024-07-02
- Date received
- 2024-04-03
- 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: K240915.pdf
Official FDA record: K240915
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.