The following data is part of a premarket notification filed by Respironics Inc., Sleep & Home Respiratory Group with the FDA for Trilogy 100 Ventilator.
| Device ID | K083526 |
| 510k Number | K083526 |
| Device Name: | TRILOGY 100 VENTILATOR |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP 1740 GOLDEN MILE HWY Monroeville, PA 15146 |
| Contact | Zita A Yurko |
| Correspondent | Zita A Yurko RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP 1740 GOLDEN MILE HWY 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 | 2008-11-28 |
| Decision Date | 2009-03-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00606959038851 | K083526 | 000 |
| 00606959026261 | K083526 | 000 |
| 00606959026278 | K083526 | 000 |
| 00606959026285 | K083526 | 000 |
| 00606959026292 | K083526 | 000 |
| 00606959026308 | K083526 | 000 |
| 00606959026315 | K083526 | 000 |
| 00606959026322 | K083526 | 000 |
| 00606959033894 | K083526 | 000 |
| 00606959026230 | K083526 | 000 |
| 30606959026200 | K083526 | 000 |
| 30606959026170 | K083526 | 000 |
| 00606959038868 | K083526 | 000 |
| 00606959023178 | K083526 | 000 |
| 00606959023185 | K083526 | 000 |
| 00606959025387 | K083526 | 000 |
| 00606959026131 | K083526 | 000 |
| 00606959026148 | K083526 | 000 |
| 00606959026155 | K083526 | 000 |
| 00606959026162 | K083526 | 000 |
| 00606959033900 | K083526 | 000 |
| 00606959038226 | K083526 | 000 |
| 00606959042933 | K083526 | 000 |
| 00606959022713 | K083526 | 000 |
| 00606959022737 | K083526 | 000 |
| 00606959022744 | K083526 | 000 |
| 00606959022751 | K083526 | 000 |
| 00606959022768 | K083526 | 000 |
| 00606959022775 | K083526 | 000 |
| 00606959022805 | K083526 | 000 |
| 00606959022829 | K083526 | 000 |
| 00606959022669 | K083526 | 000 |
| 00606959022171 | K083526 | 000 |
| 00606959022058 | K083526 | 000 |
| 00606959042940 | K083526 | 000 |
| 30606959043023 | K083526 | 000 |
| 00606959047402 | K083526 | 000 |
| 00606959005211 | K083526 | 000 |
| 00606959005228 | K083526 | 000 |
| 00606959015364 | K083526 | 000 |
| 00606959020764 | K083526 | 000 |
| 00606959021662 | K083526 | 000 |
| 00606959022836 | K083526 | 000 |