K201306 is an FDA 510(k) clearance for the HAMILTON-C3. This device is classified as a Ventilator, Continuous, Facility Use (Class II - Special Controls, product code CBK).
Submitted by Hamilton Medical AG (Bonaduz, CH). The FDA issued a Cleared decision on February 5, 2021, 266 days after receiving the submission on May 15, 2020.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5895.
| 510(k) Number | K201306 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 15, 2020 |
| Decision Date | February 05, 2021 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CBK — Ventilator, Continuous, Facility Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5895 |