The following data is part of a premarket notification filed by Covidien Lp with the FDA for Puritan Bennett 840 Series Ventilator System.
| Device ID | K151252 |
| 510k Number | K151252 |
| Device Name: | Puritan Bennett 840 Series Ventilator System |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | Covidien LP 6135 Gunbarrel Ave Boulder, CO 80301 |
| Contact | Kelsey Lee |
| Correspondent | Kelsey Lee Covidien LP 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 | 2015-05-12 |
| Decision Date | 2016-03-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521254609 | K151252 | 000 |
| 10884521658318 | K151252 | 000 |
| 10884521658301 | K151252 | 000 |
| 10884521658295 | K151252 | 000 |
| 10884521658288 | K151252 | 000 |
| 10884521101258 | K151252 | 000 |
| 10884521101241 | K151252 | 000 |