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 |