The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Trilogy 202 Ventilator.
| Device ID | K093905 |
| 510k Number | K093905 |
| Device Name: | TRILOGY 202 VENTILATOR |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | RESPIRONICS, INC. 1740 GOLDEN MILE HIGHWAY Monroeville, PA 15146 |
| Contact | Joseph Olsavsky |
| Correspondent | Joseph Olsavsky RESPIRONICS, INC. 1740 GOLDEN MILE HIGHWAY Monroeville, PA 15146 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-22 |
| Decision Date | 2010-05-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00606959022812 | K093905 | 000 |
| 00606959026247 | K093905 | 000 |
| 00606959026254 | K093905 | 000 |
| 00606959033870 | K093905 | 000 |
| 00606959033887 | K093905 | 000 |
| 00606959033948 | K093905 | 000 |
| 00606959050686 | K093905 | 000 |
| 00606959052369 | K093905 | 000 |
| 00606959005150 | K093905 | 000 |
| 00606959022065 | K093905 | 000 |
| 00606959022096 | K093905 | 000 |
| 00606959022706 | K093905 | 000 |
| 00606959022720 | K093905 | 000 |
| 00606959022799 | K093905 | 000 |
| 00606959025394 | K093905 | 000 |