K082966 is an FDA 510(k) clearance for the PB 540 VENTILATOR. This device is classified as a Ventilator, Continuous, Facility Use (Class II - Special Controls, product code CBK).
Submitted by Covidien, Formerly Nellcor Puritan Bennett, Inc. (Boulder, US). The FDA issued a Cleared decision on October 31, 2008, 25 days after receiving the submission on October 6, 2008.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5895.
| 510(k) Number | K082966 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 06, 2008 |
| Decision Date | October 31, 2008 |
| Days to Decision | 25 days |
| Submission Type | Special |
| 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 |