The following data is part of a premarket notification filed by Covidien, Formerly Nellcor Puritan Bennett Inc. with the FDA for Pb 540 Ventilator.
| Device ID | K082966 |
| 510k Number | K082966 |
| Device Name: | PB 540 VENTILATOR |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT INC. 6135 Gunbarrel Ave Boulder, CO 80301 |
| Contact | Tina O'brien |
| Correspondent | Tina O'brien 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-06 |
| Decision Date | 2008-10-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521100258 | K082966 | 000 |
| 20884521100241 | K082966 | 000 |
| 20884521784687 | K082966 | 000 |
| 20884521784670 | K082966 | 000 |