K071175 is an FDA 510(k) clearance for the OHMEDA MEDICAL GIRAFFE OMNIBED. This device is classified as a Incubator, Neonatal (Class II - Special Controls, product code FMZ).
Submitted by Ge Healthcare (Laurel, US). The FDA issued a Cleared decision on July 17, 2007, 81 days after receiving the submission on April 27, 2007.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5400.
| 510(k) Number | K071175 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 27, 2007 |
| Decision Date | July 17, 2007 |
| Days to Decision | 81 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 |