Giraffe Omnibed Carestation CS1
FDA 510(k) clearance K213551 · decided 2022-03-02
Clearance details
- K-number
- K213551
- Device name
- Giraffe Omnibed Carestation CS1
- Applicant
- Datex Ohmeda, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-11-08
- Decision date
- 2022-03-02
- Days to decision
- 114 days
- Clearance type
- Traditional
- Product code
- FMT
- Device class
- 2
- Regulation number
- 880.5130
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Wauwatosa, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1, a combination of an infa recall (Z-2476-2026) | GE Medical Systems, LLC | 2026-06-17 |
| Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-50 recall (Z-2477-2026) | GE Medical Systems, LLC | 2026-06-17 |
| GE Healthcare Giraffe Omnibed Carestation CS1, combination infant incubator and infant war recall (Z-0140-2025) | DATEX--OHMEDA, INC. | 2024-10-31 |
| GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo natal incubato recall (Z-0048-2025) | DATEX--OHMEDA, INC. | 2024-10-17 |
| Giraffe OmniBed Carestation CS1, Model Numbers: a. 2082844-001-XXX, b. 2074920-001-XXXXXX, recall (Z-2100-2023) | DATEX--OHMEDA, INC. | 2023-07-06 |