Carestation 750/750c
FDA 510(k) clearance K213867 · decided 2023-03-28
Clearance details
- K-number
- K213867
- Device name
- Carestation 750/750c
- Applicant
- Datex-Ohmeda, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-12-10
- Decision date
- 2023-03-28
- Days to decision
- 473 days
- Clearance type
- Traditional
- Product code
- BSZ
- Device class
- 2
- Regulation number
- 868.5160
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Madison, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 7 recall (Z-0914-2026) | GE Medical Systems China Co., Ltd. | 2025-12-18 |
| GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable recall (Z-0915-2026) | GE Medical Systems China Co., Ltd. | 2025-12-18 |
| GE Healthcare CARESTATION 750 A1, Model/REF Number 1012-9750-000. Anesthesia system. recall (Z-1635-2025) | GE Medical Systems China Co., Ltd. | 2025-04-29 |
| GE Healthcare CARESTATION 750c A1, Model/REF Number 1012-9755-000. Anesthesia system. recall (Z-1637-2025) | GE Medical Systems China Co., Ltd. | 2025-04-29 |