510(k) K213867 ยท BSZ Gas-Machine, Anesthesia
Carestation 750/750c
| Applicant | Datex-Ohmeda, Inc., Madison WI, US |
| Decision | Substantially Equivalent, Mar 28, 2023 |
| Received | Dec 10, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213867
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 18, 2025 | GE Medical Systems China Co., Ltd. GE Healthcare Carestation anesthesia system, product number and REF numbers:
Carestation 750 A1, REF 1012-9750-000;
Carestation 750 A2, REF 1012-9750-002;
Carestation 750c A1, REF 1012-9755-000;
Open, Classified |
BSZ | None listed |
| Dec 18, 2025 | GE Medical Systems China Co., Ltd. GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU), 2076139-001-S Open, Classified |
BSZ | None listed |
| Apr 29, 2025 | GE Medical Systems China Co., Ltd. GE Healthcare CARESTATION 750 A1, Model/REF Number 1012-9750-000. Anesthesia system. Open, Classified |
BSZ | None listed |
| Apr 29, 2025 | GE Medical Systems China Co., Ltd. GE Healthcare CARESTATION 750c A1, Model/REF Number 1012-9755-000. Anesthesia system. Open, Classified |
BSZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.