The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Trilogy Series Ventilator With Oximetry.
| Device ID | K111610 |
| 510k Number | K111610 |
| Device Name: | TRILOGY SERIES VENTILATOR WITH OXIMETRY |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | RESPIRONICS, INC. 1740 GOLDEN MILE HIGHWAY Monroeville, PA 15146 |
| Contact | Joseph E Olsavsky |
| Correspondent | Joseph E Olsavsky RESPIRONICS, INC. 1740 GOLDEN MILE HIGHWAY Monroeville, PA 15146 |
| Product Code | CBK |
| Subsequent Product Code | DQA |
| Subsequent Product Code | NOU |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-09 |
| Decision Date | 2011-10-14 |
| Summary: | summary |