The following data is part of a premarket notification filed by Covidien Llc with the FDA for Puritan Bennett Cuff Pressure Manager.
| Device ID | K202874 |
| 510k Number | K202874 |
| Device Name: | Puritan Bennett Cuff Pressure Manager |
| Classification | Cuff, Tracheal Tube, Inflatable |
| Applicant | Covidien Llc 6F, Building 3, 2388 Chenhang Road Shanghai, CN 201114 |
| Contact | Jenny Liu |
| Correspondent | Jenny Liu Covidien Llc 6F, Building 3, 2388 Chenhang Road Shanghai, CN 201114 |
| Product Code | BSK |
| CFR Regulation Number | 868.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-28 |
| Decision Date | 2021-01-09 |