ONM

Radiant Infant Warmer Cabinet

Product code: ONM
Device name: Radiant Infant Warmer Cabinet
Device class: Class 2
21 CFR: 21 CFR 880.5130
Medical specialty: General Hospital
Marketing pathway: 510(K)
Flag: Third-party review eligible

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: ONM

Classification and pathway per current FDA publications. Data from openFDA (CC0).