K122267 is an FDA 510(k) clearance for the GIRAFFE AND PANDA WARMERS. This device is classified as a Warmer, Infant Radiant (Class II - Special Controls, product code FMT).
Submitted by Ohmeda Medical, A Division of Datex-Ohmeda, Inc. (Laurel, US). The FDA issued a Cleared decision on October 2, 2012, 64 days after receiving the submission on July 30, 2012.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5130.
| 510(k) Number | K122267 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 30, 2012 |
| Decision Date | October 02, 2012 |
| Days to Decision | 64 days |
| Submission Type | Special |
| 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 |