Hamilton-C6— 510(k) K201658
Substantially EquivalentHamilton Medical AG
FDA 510(k) clearance K201658 for Hamilton-C6, Substantially Equivalent on 2020-12-11. Applicant: Hamilton Medical AG. Device class: 2.
Clearance details
- Applicant
- Hamilton Medical AG
- Product code
- Code CBK
- Device class
- Class 2
- Regulation
- 21 CFR 868.5895
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bonaduz, CH
Recent devices under product code CBK
view allMore clearances from Hamilton Medical AG
view allAdverse events under product code CBK
product code CBK- Death
- 736
- Injury
- 3,628
- Malfunction
- 98,786
- Other
- 4
- Total
- 103,154
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 K201658
K-number listed on FDA's recall record- Z-2328-2025 — Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 is a ventilator intended to provide positive pressure ventilatory support to adults and pediatrics and optionally infants and neonates.
- Z-2020-2024 — Ventilator HAMILTON-C6, PN: 160021
- Z-1429-2023 — HAMILTON-C6, REF: 160021
- Z-0267-2023 — Hamilton-C6
- Z-1525-2022 — HAMILTON-C6 Intensive Care Ventilator, REF: 160021
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K201658.
Data sourced from openFDA. This site is unofficial and independent of the FDA.