The following data is part of a premarket notification filed by Ohmeda Medical, A Division Of Datex-ohmeda,inc. A Ge Company with the FDA for Giraffe Omnibed Carestation Cs1.
| Device ID | K152814 |
| 510k Number | K152814 |
| Device Name: | Giraffe OmniBed Carestation CS1 |
| Classification | Incubator, Neonatal |
| Applicant | Ohmeda Medical, A Division Of Datex-Ohmeda,Inc. A GE Company 8880 Gorman Rooad Laurel, MD 20723 |
| Contact | Kenny M Bello |
| Correspondent | Kenny M Bello Ohmeda Medical, A Division Of Datex-Ohmeda,Inc. A GE Company 8880 Gorman Rooad Laurel, MD 20723 |
| Product Code | FMZ |
| CFR Regulation Number | 880.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-28 |
| Decision Date | 2016-03-17 |
| Summary: | summary |