The following data is part of a premarket notification filed by Covidien, Llc with the FDA for Puritan Bennett 980 Series Ventilator System.
| Device ID | K193056 |
| 510k Number | K193056 |
| Device Name: | Puritan Bennett 980 Series Ventilator System |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | Covidien, LLC 6135 Gunbarrel Ave Boulder, CO 80301 |
| Contact | Zheng Liu |
| Correspondent | Zheng Liu Covidien, LLC 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 | 2019-11-01 |
| Decision Date | 2020-11-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521817609 | K193056 | 000 |
| 10884521817593 | K193056 | 000 |
| 10884521817586 | K193056 | 000 |
| 10884521808546 | K193056 | 000 |
| 10884521808003 | K193056 | 000 |
| 10884521802469 | K193056 | 000 |
| 10884521211551 | K193056 | 000 |
| 10884521145153 | K193056 | 000 |
| 20884521803302 | K193056 | 000 |