The following data is part of a premarket notification filed by Covidien with the FDA for Puritan Bennett 980 Ventilator System.
| Device ID | K162738 |
| 510k Number | K162738 |
| Device Name: | Puritan Bennett 980 Ventilator System |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | Covidien 6135 Gunbarrel Ave Boulder, CO 80301 |
| Contact | Kelsey Lee |
| Correspondent | Kelsey Lee Covidien 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 | 2016-09-30 |
| Decision Date | 2017-10-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521723600 | K162738 | 000 |
| 10884521143562 | K162738 | 000 |
| 10884521659117 | K162738 | 000 |
| 10884521188754 | K162738 | 000 |
| 10884521188785 | K162738 | 000 |
| 10884521593411 | K162738 | 000 |
| 10884521659100 | K162738 | 000 |
| 20884521252940 | K162738 | 000 |
| 20884521609102 | K162738 | 000 |
| 30884521252954 | K162738 | 000 |
| 10884521592810 | K162738 | 000 |
| 20884521164236 | K162738 | 000 |