The following data is part of a premarket notification filed by Covidien, Formerly Nellcor Puritan Bennett, Inc. with the FDA for 840 Ventilator System With Expanded Neomode Option.
| Device ID | K092847 |
| 510k Number | K092847 |
| Device Name: | 840 VENTILATOR SYSTEM WITH EXPANDED NEOMODE OPTION |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT, INC. 6135 GUNBARREL AVE. Boulder, CO 80301 |
| Contact | Jean Simon |
| Correspondent | Jean Simon COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT, INC. 6135 GUNBARREL AVE. Boulder, CO 80301 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-16 |
| Decision Date | 2010-03-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521083479 | K092847 | 000 |