K243606
- 510(k) number
- K243606
- Device name
- Babyroo TN300
- Applicant
- Draeger Medical Systems, Inc. PA · US
- Product code
- FMT — Warmer, Infant Radiant
- Decision date
- 2025-01-17
- Date received
- 2024-11-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K243606.pdf
Official FDA record: K243606
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.