K243606 is an FDA 510(k) clearance for the Babyroo TN300. This device is classified as a Warmer, Infant Radiant (Class II - Special Controls, product code FMT).
Submitted by Draeger Medical Systems, Inc. (Telford, US). The FDA issued a Cleared decision on January 17, 2025, 57 days after receiving the submission on November 21, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5130.
| 510(k) Number | K243606 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 21, 2024 |
| Decision Date | January 17, 2025 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMT — Warmer, Infant Radiant |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5130 |