The following data is part of a premarket notification filed by Respironics Inc. with the FDA for Trilogy Evo Universal.
| Device ID | K181170 |
| 510k Number | K181170 |
| Device Name: | Trilogy Evo Universal |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | Respironics Inc. 1001 Murry Ridge Lane Murrysville, PA 15668 |
| Contact | Colleen Witt |
| Correspondent | Colleen Witt Respironics Inc. 1740 Golden Mile Highway Monroeville, PA 15146 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-02 |
| Decision Date | 2019-07-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00606959052000 | K181170 | 000 |