HAMILTON-G5
FDA 510(k) clearance K103803 · decided 2011-11-23
Clearance details
- K-number
- K103803
- Device name
- HAMILTON-G5
- Applicant
- Hamilton Medical AG
- Decision
- Substantially Equivalent
- Date received
- 2010-12-28
- Decision date
- 2011-11-23
- Days to decision
- 330 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
+ Add to Predicate Builder ◉ Watch Hamilton Medical AG
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
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 Ventilators with software versions V2.40/2.41 Catalog numbers for G5: 159001 a recall (Z-2057-2015) | Hamilton Medical, Inc. | 2015-07-10 |
| HAMILTON G5 ventilators with software version V2.0x. Hamilton Medical AG, Switzerland Impo recall (Z-1185-2012) | Hamilton Medical Inc | 2012-03-07 |