Carestation 750/750c— 510(k) K213867
Substantially EquivalentDatex-Ohmeda, Inc.
FDA 510(k) clearance K213867 for Carestation 750/750c, Substantially Equivalent on 2023-03-28. Applicant: Datex-Ohmeda, Inc.. Device class: 2.
Clearance details
- Applicant
- Datex-Ohmeda, Inc.
- Product code
- Code BSZ
- Device class
- Class 2
- Regulation
- 21 CFR 868.5160
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Madison, WI, US
Recent devices under product code BSZ
view allMore clearances from Datex-Ohmeda, Inc.
view allAdverse events under product code BSZ
product code BSZ- Death
- 23
- Injury
- 298
- Malfunction
- 32,987
- Total
- 33,308
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K213867
K-number listed on FDA's recall record- Z-0914-2026 — 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; Products for which affected PMB can be used as a spare part: Carestation 750c A2, REF 1012-9755-002
- Z-0915-2026 — GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU), 2076139-001-S
- Z-1635-2025 — GE Healthcare CARESTATION 750 A1, Model/REF Number 1012-9750-000
- Z-1637-2025 — GE Healthcare CARESTATION 750c A1, Model/REF Number 1012-9755-000
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K213867.
Data sourced from openFDA. This site is unofficial and independent of the FDA.