K213098 is an FDA 510(k) clearance for the Panther 5. This device is classified as a Ventilator, Continuous, Facility Use (Class II - Special Controls, product code CBK).
Submitted by Origin Medical Devices (Newport Beach, US). The FDA issued a Cleared decision on July 20, 2023, 664 days after receiving the submission on September 24, 2021.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5895.
| 510(k) Number | K213098 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 24, 2021 |
| Decision Date | July 20, 2023 |
| Days to Decision | 664 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | CBK - Ventilator, Continuous, Facility Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5895 |