The following data is part of a premarket notification filed by Respironics Inc. with the FDA for Care Orchestrator Essence.
| Device ID | K183226 |
| 510k Number | K183226 |
| Device Name: | Care Orchestrator Essence |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | Respironics Inc. 1001 Murry Ridge Lane Murrysville, PA 15642 |
| Contact | Michelle Brinker |
| Correspondent | Jennifer Rochardson Respironics Inc. 1001 Murry Ridge Lane Murrysville, PA 15642 |
| Product Code | BZD |
| Subsequent Product Code | CBK |
| Subsequent Product Code | MNS |
| Subsequent Product Code | MNT |
| Subsequent Product Code | NOU |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-20 |
| Decision Date | 2019-10-18 |