K243901
- 510(k) number
- K243901
- Device name
- SmartPilot YpsoMate NS-A2.25
- Applicant
- Ypsomed AG CH
- Product code
- QOG — Injection Data Capture Device
- Decision date
- 2025-08-28
- Date received
- 2024-12-19
- 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: K243901.pdf
Official FDA record: K243901
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.