Product code ONM
- Device name
- Radiant Infant Warmer Cabinet
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.5130
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Definition
- The device is intended to provide an enclosure for storage of an radiant infant warmer. It may also provide a bassinet for use with the radiant infant warmer, and provide power to the infant radiant warmer.
- Source
- FDA openFDA device classification dataset