The following data is part of a premarket notification filed by Covidien, Formerly Nellcor Puritan Bennett Inc. with the FDA for Pb 840 Ventilator System With Leak Compensation Option, Model 840.
| Device ID | K083693 |
| 510k Number | K083693 |
| Device Name: | PB 840 VENTILATOR SYSTEM WITH LEAK COMPENSATION OPTION, MODEL 840 |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT INC. 2101 FARADAY AVENUE Carlsbad, CA 92008 |
| Contact | Kim Bloom |
| Correspondent | Kim Bloom COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT INC. 2101 FARADAY AVENUE Carlsbad, CA 92008 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-12 |
| Decision Date | 2009-04-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521640863 | K083693 | 000 |