K131252 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 (Boulder, US). The FDA issued a Cleared decision on February 24, 2014, 298 days after receiving the submission on May 2, 2013.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5895.
| 510(k) Number | K131252 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 02, 2013 |
| Decision Date | February 24, 2014 |
| Days to Decision | 298 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 |