510(k) K243372
K243372 is an FDA 510(k) premarket notification submitted by Gerium Medical, Ltd. for the device "BiliWrap". The FDA issued a decision of Substantially Equivalent on May 29, 2025. The device falls under product code LBI (Unit, Neonatal Phototherapy), a Class II device regulated under 21 CFR 880.5700.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 29, 2025
- Date Received
- October 30, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Neonatal Phototherapy
- Device Class
- Class II
- Regulation Number
- 880.5700
- Review Panel
- HO
- Submission Type