Hamilton-C6
FDA 510(k) clearance K201658 · decided 2020-12-11
Clearance details
- K-number
- K201658
- Device name
- Hamilton-C6
- Applicant
- Hamilton Medical AG
- Decision
- Substantially Equivalent
- Date received
- 2020-06-18
- Decision date
- 2020-12-11
- Days to decision
- 176 days
- Clearance type
- Traditional
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Bonaduz, CH
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 recall (Z-2328-2025) | Hamilton Medical AG | 2025-08-19 |
| Ventilator HAMILTON-C6, PN: 160021 recall (Z-2020-2024) | Hamilton Medical AG | 2024-06-18 |
| HAMILTON-C6, REF: 160021 recall (Z-1429-2023) | Hamilton Medical AG | 2023-04-25 |
| Hamilton-C6 recall (Z-0267-2023) | Hamilton Medical AG | 2022-11-18 |