ONM — Radiant Infant Warmer Cabinet Class II
FDA product code ONM covers "Radiant Infant Warmer Cabinet", a Class II medical device regulated under 21 CFR 880.5130. Submissions are reviewed by the General Hospital panel.
Classification Details
- Product Code
- ONM
- Device Class
- Class II
- Regulation Number
- 880.5130
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
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.