K251619
- 510(k) number
- K251619
- Device name
- Babyleo TN500
- Applicant
- Drägerwerk AG & Co. KGaA DE
- Product code
- FMZ — Incubator, Neonatal
- Decision date
- 2026-02-13
- Date received
- 2025-05-27
- 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: K251619.pdf
Official FDA record: K251619
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.