FMZ
- Product code
- FMZ
- Device name
- Incubator, Neonatal
- Device class
- Class 2
- 21 CFR
- 21 CFR 880.5400
- Medical specialty
- General Hospital
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 4
- Summaries archived here
- 4 (direct download)
- 510(k) clearances (all years, FDA)
- 86 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (4)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260326 | 2026-07-28 | Datex-Ohmeda, Inc. | Giraffe OmniBed Carestation (CS1); Giraffe Incuba… | |
| K251619 | 2026-02-13 | Drägerwerk AG & Co. KGaA | Babyleo TN500 | |
| K251663 | 2025-10-22 | Datex-Ohmeda, Inc. | Giraffe OmniBed Carestation (CS1); Giraffe Incubator… | |
| K243437 | 2025-08-14 | Mom Incubators Limited | mOm Essential Incubator (ME1) |
Official FDA classification page: FMZ
Classification and pathway per current FDA publications. Data from openFDA (CC0).