HAMILTON-MR1
FDA 510(k) clearance K122438 · decided 2013-11-20
Clearance details
- K-number
- K122438
- Device name
- HAMILTON-MR1
- Applicant
- Hamilton Medical AG
- Decision
- Substantially Equivalent
- Date received
- 2012-08-10
- Decision date
- 2013-11-20
- Days to decision
- 467 days
- Clearance type
- Abbreviated
- 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-MR1 Ventilator: Catalog# 161010 The Hamilton MR1 Ventilator is intended to provid recall (Z-0666-2017) | Hamilton Medical, Inc. | 2016-11-28 |