K072512 is an FDA 510(k) clearance for the MODIFICATION TO: OHMEDA MEDICAL GIRAFFE INCUBATOR (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY). This device is classified as a Incubator, Neonatal (Class II - Special Controls, product code FMZ).
Submitted by Datex-Ohmeda, Inc. (Laurel, US). The FDA issued a Cleared decision on October 3, 2007, 27 days after receiving the submission on September 6, 2007.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5400.
| 510(k) Number | K072512 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 06, 2007 |
| Decision Date | October 03, 2007 |
| Days to Decision | 27 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMZ — Incubator, Neonatal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5400 |