FMT
- Product code
- FMT
- Device name
- Warmer, Infant Radiant
- Device class
- Class 2
- 21 CFR
- 21 CFR 880.5130
- Medical specialty
- General Hospital
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 92
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K243606 | 2025-01-17 | Draeger Medical Systems, Inc. | Babyroo TN300 |
Official FDA classification page: FMT
Classification and pathway per current FDA publications. Data from openFDA (CC0).