K230278 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 May 30, 2023, 118 days after receiving the submission on February 1, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5130.
| 510(k) Number | K230278 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 01, 2023 |
| Decision Date | May 30, 2023 |
| Days to Decision | 118 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 |