ONM · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.5130
Classification
FDA Product Code
ONM
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 880.5130
Review panel
HO
Medical specialty
General Hospital
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y
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.