K243372
- 510(k) number
- K243372
- Device name
- BiliWrap
- Applicant
- Gerium Medical, Ltd. IL
- Product code
- LBI — Unit, Neonatal Phototherapy
- Decision date
- 2025-05-29
- Date received
- 2024-10-30
- 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: K243372.pdf
Official FDA record: K243372
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.