HAMILTON-T1, HAMILTON-C1
FDA 510(k) clearance K181216 · decided 2019-08-02
Clearance details
- K-number
- K181216
- Device name
- HAMILTON-T1, HAMILTON-C1
- Applicant
- Hamilton Medical AG
- Decision
- Substantially Equivalent
- Date received
- 2018-05-07
- Decision date
- 2019-08-02
- Days to decision
- 452 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-C1, REF: 161001, Portable Intensive Care Ventilator recall (Z-2525-2023) | Hamilton Medical, Inc. | 2023-09-20 |
| Hamilton-T1, REF: 161006, Intensive Care and Transport Ventilator recall (Z-2526-2023) | Hamilton Medical, Inc. | 2023-09-20 |
| Hamilton-T1, REF: 161009, Intensive Care and Transport Ventilator recall (Z-2527-2023) | Hamilton Medical, Inc. | 2023-09-20 |
| HAMILTON C1 Ventilator REF 161001 1610010 Is intended to provide positive pressure ventila recall (Z-2139-2023) | Hamilton Medical, Inc. | 2023-07-21 |
| HAMILTON T1 Ventilator REF 161006 1610060 161009 1610090 Is intended to provide positive p recall (Z-2140-2023) | Hamilton Medical, Inc. | 2023-07-21 |