K213553 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 Datex-Ohmeda, Inc. (Wauwatosa, US). The FDA issued a Cleared decision on March 2, 2022, 114 days after receiving the submission on November 8, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5400.
| 510(k) Number | K213553 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 2021 |
| Decision Date | March 02, 2022 |
| Days to Decision | 114 days |
| Submission Type | Traditional |
| 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 |