HAMILTON-MR1
FDA 510(k) clearance K153046 · decided 2016-09-06
Clearance details
- K-number
- K153046
- Device name
- HAMILTON-MR1
- Applicant
- Hamilton Medical AG
- Decision
- Substantially Equivalent
- Date received
- 2015-10-19
- Decision date
- 2016-09-06
- Days to decision
- 323 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-MR1, REF: 161010, Intensive Care Ventilator recall (Z-2528-2023) | Hamilton Medical, Inc. | 2023-09-20 |