FDA Product Code FMZ: Incubator, Neonatal
Leading manufacturers include Datex-Ohmeda, Inc..
2
Total
2
Cleared
130d
Avg days
2022
Since
List of Incubator, Neonatal devices cleared through 510(k)
2 devices
Cleared
Oct 22, 2025
Giraffe OmniBed Carestation (CS1)
Datex-Ohmeda, Inc.
General Hospital
145d
Cleared
Mar 02, 2022
Giraffe Incubator Carestation CS1
Datex-Ohmeda, Inc.
General Hospital
114d
How to use this database
This page lists all FDA 510(k) submissions for Incubator, Neonatal devices (product code FMZ). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the General Hospital FDA review panel. Browse all General Hospital devices →