K101804 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 July 21, 2010, 23 days after receiving the submission on June 28, 2010.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5130.
| 510(k) Number | K101804 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 28, 2010 |
| Decision Date | July 21, 2010 |
| Days to Decision | 23 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 |