K152809 is an FDA 510(k) clearance for the Giraffe Incubator Carestation CS1. This device is classified as a Incubator, Neonatal (Class II - Special Controls, product code FMZ).
Submitted by Ohmeda Medical, A Division of Datex-Ohmeda, Inc. (Laurel, US). The FDA issued a Cleared decision on December 31, 2015, 94 days after receiving the submission on September 28, 2015.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5400.
| 510(k) Number | K152809 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 2015 |
| Decision Date | December 31, 2015 |
| Days to Decision | 94 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 |