K193056 is an FDA 510(k) clearance for the Puritan Bennett 980 Series Ventilator System. This device is classified as a Ventilator, Continuous, Facility Use (Class II - Special Controls, product code CBK).
Submitted by Covidien, LLC (Boulder, US). The FDA issued a Cleared decision on November 20, 2020, 385 days after receiving the submission on November 1, 2019.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5895.
| 510(k) Number | K193056 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 01, 2019 |
| Decision Date | November 20, 2020 |
| Days to Decision | 385 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 |