MODIFICATION TO HAMILTON-G5
FDA 510(k) clearance K081521 · decided 2008-09-25
Clearance details
- K-number
- K081521
- Device name
- MODIFICATION TO HAMILTON-G5
- Applicant
- Hamilton Medical AG
- Decision
- Substantially Equivalent
- Date received
- 2008-05-30
- Decision date
- 2008-09-25
- Days to decision
- 118 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 Ventilator with software version V2.00x and Neonatal Option or V2.01x and Neon recall (Z-1928-2011) | Hamilton Medical Inc | 2011-04-08 |