K252104
- 510(k) number
- K252104
- Device name
- T1D1
- Applicant
- Comerge AG CH
- Product code
- NDC — Calculator, Drug Dose
- Decision date
- 2025-08-20
- Date received
- 2025-07-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K252104.pdf
Official FDA record: K252104
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.