HAMILTON-G5
FDA 510(k) clearance K131774 · decided 2013-10-09
Clearance details
- K-number
- K131774
- Device name
- HAMILTON-G5
- Applicant
- Hamilton Medical AG
- Decision
- Substantially Equivalent
- Date received
- 2013-06-17
- Decision date
- 2013-10-09
- Days to decision
- 114 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-G5, with software versions less than or equal to 2.60 The HAMILTON-G5/S1 ventilat recall (Z-1874-2019) | Hamilton Medical AG | 2019-07-11 |
| Hamilton G5 with software version between v2.41, v2.42, v2.50. Catalog number: 1590001 and recall (Z-1624-2016) | Hamilton Medical, Inc. | 2016-05-09 |
| HAMILTON-G5 Ventilator with software versions between V2.00 and V2.31. Anesthesiology: The recall (Z-0151-2016) | Hamilton Medical, Inc. | 2015-11-04 |
| Hamilton-G5 Ventilators with software versions V2.40/2.41 Catalog numbers for G5: 159001 a recall (Z-2057-2015) | Hamilton Medical, Inc. | 2015-07-10 |