The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Trilogy 200 Ventilator.
| Device ID | K093416 |
| 510k Number | K093416 |
| Device Name: | TRILOGY 200 VENTILATOR |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | RESPIRONICS, INC. 1740 GOLDEN MILE HIGHWAY Monroeville, PA 15146 |
| Contact | Zita Yurko |
| Correspondent | Zita Yurko 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 | 2009-11-02 |
| Decision Date | 2010-01-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00606959047419 | K093416 | 000 |
| 00606959025370 | K093416 | 000 |
| 00606959026223 | K093416 | 000 |
| 30606959026071 | K093416 | 000 |
| 40606959026061 | K093416 | 000 |
| 40606959026054 | K093416 | 000 |
| 00606959050099 | K093416 | 000 |
| 00606959022843 | K093416 | 000 |
| 00606959022690 | K093416 | 000 |
| 00606959022683 | K093416 | 000 |
| 00606959038875 | K093416 | 000 |
| 30606959024220 | K093416 | 000 |
| 40606959026214 | K093416 | 000 |
| 00606959042926 | K093416 | 000 |
| 00606959038233 | K093416 | 000 |
| 00606959033931 | K093416 | 000 |
| 00606959033924 | K093416 | 000 |
| 00606959033917 | K093416 | 000 |
| 00606959033863 | K093416 | 000 |
| 00606959033856 | K093416 | 000 |
| 00606959033849 | K093416 | 000 |
| 00606959027763 | K093416 | 000 |
| 00606959022089 | K093416 | 000 |