K201628 is an FDA 510(k) clearance for the Panda iRes Warmer, Giraffe Warmer. This device is classified as a Warmer, Infant Radiant (Class II - Special Controls, product code FMT).
Submitted by Ge Healthcare (Wauwatosa, US). The FDA issued a Cleared decision on February 12, 2021, 241 days after receiving the submission on June 16, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5130.
| 510(k) Number | K201628 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 16, 2020 |
| Decision Date | February 12, 2021 |
| Days to Decision | 241 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 |