PDH — Blanket, Neonatal Phototherapy Class II
FDA product code PDH covers "Blanket, Neonatal Phototherapy", a Class II medical device regulated under 21 CFR 880.5700. Submissions are reviewed by the General Hospital panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PDH
- Device Class
- Class II
- Regulation Number
- 880.5700
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
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.