K092847 is an FDA 510(k) clearance for the 840 VENTILATOR SYSTEM WITH EXPANDED NEOMODE OPTION. 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 March 11, 2010, 176 days after receiving the submission on September 16, 2009.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5895.
| 510(k) Number | K092847 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 16, 2009 |
| Decision Date | March 11, 2010 |
| Days to Decision | 176 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 |