510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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ONMClass II

Radiant Infant Warmer Cabinet

21 CFR 880.5130 / General Hospital
FDA source (opens on fda.gov)

ONM is the FDA product code for Radiant Infant Warmer Cabinet, a class II device type, regulated under 21 CFR 880.5130. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
ONM
Device name
Radiant Infant Warmer Cabinet
FDA 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.
Regulation
21 CFR 880.5130
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code ONM.