The following data is part of a premarket notification filed by Respironics Inc. with the FDA for Trilogy Evo.
| Device ID | K181166 |
| 510k Number | K181166 |
| Device Name: | Trilogy Evo |
| 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 |
|---|---|---|
| 30606959049551 | K181166 | 000 |
| 00606959052017 | K181166 | 000 |
| 00606959055582 | K181166 | 000 |
| 00606959057456 | K181166 | 000 |
| 00606959061019 | K181166 | 000 |
| 00606959061026 | K181166 | 000 |
| 00606959061033 | K181166 | 000 |
| 00606959055704 | K181166 | 000 |
| 00606959055636 | K181166 | 000 |
| 00606959052307 | K181166 | 000 |
| 00606959052314 | K181166 | 000 |
| 00606959047624 | K181166 | 000 |
| 00606959051942 | K181166 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() TRILOGY EVO 79231179 5663637 Live/Registered |
Koninklijke Philips N.V. 2018-03-12 |