Product code PDH
- Device name
- Blanket, Neonatal Phototherapy
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.5700
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Definition
- Is intended to be used as an adjunct to neonatal phototherapy systems used for the treatment of neonatal hyperbilirubinemia in the clinical or home setting.
- Source
- FDA openFDA device classification dataset