Carestation 620/650/650C— 510(k) K151570
Substantially EquivalentDatex-Ohmeda, Inc.
FDA 510(k) clearance K151570 for Carestation 620/650/650C, Substantially Equivalent on 2016-01-21. 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 K151570
K-number listed on FDA's recall record- Z-0913-2026 — GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1, REF 1012-9620-222; Carestation 620 A1 REF 1012-9620-000; Carestation 620 A1, REF 1012-9620-200; Carestation 620 A1, REF 1012-9620-202; Carestation 620 SE A1, REF 1012-9620-212; Carestation 630 A1, REF 1012-9650-222; Carestation 650 A1, REF 1012-9650-000; Carestation 650 A1, REF 1012-9650-200; Carestation 650 A1, REF 1012-9650-202; Carestation 650 SE A1, REF 1012-9650-212; Carestation 650c A1, REF 1012-9655-202; Anesthesia Gas Machine Products for which affected PMB can be used as a spare part: Carestation 620 A2, REF 1012-9620-002 00840682124546 Carestation 620 SE A2, REF 1012-9620-012 00195278569677 Carestation 650 A2, REF 1012-9650-002 00840682124560 Carestation 650 SE A2, REF 1012-9650-012 00195278569684 Carestation 650c A1, REF 1012-9655-000 00840682103954 Carestation 650c A2, REF 1012-9655-002 00840682124539 Carestation 650c A1, REF 1012-9655-200 00195278439543
- Z-0915-2026 — GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU), 2076139-001-S
- Z-1624-2025 — GE Healthcare CARESTATION 620 A1, Model/REF Number 1012-9620-000
- Z-1627-2025 — GE Healthcare Carestation 620 A1, Model/REF Number 1012-9620-200
- Z-1628-2025 — GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000
- Z-1631-2025 — GE Healthcare Carestation 650 A1, Model/REF Number 1012-9650-200
- Z-1632-2025 — GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000
- Z-1634-2025 — GE Healthcare Carestation 650c A1, Model/REF Number 1012-9655-200
- Z-0813-2020 — Carestation 620/650/650c A1 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (pediatric and adult.
- Z-2954-2018 — GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems
- Z-2955-2018 — GE Carestation 30 anesthesia systems
- Z-2956-2018 — GE 9100c NXT anesthesia systems
- Z-0579-2018 — Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1
- Z-2703-2017 — Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K151570.
Data sourced from openFDA. This site is unofficial and independent of the FDA.