The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Care Cycle Connect Application.
| Device ID | K161411 |
| 510k Number | K161411 |
| Device Name: | Care Cycle Connect Application |
| Classification | Accessory To Continuous Ventilator (respirator) |
| Applicant | RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysvilles, PA 15668 |
| Contact | Colleen Witt |
| Correspondent | Elaine Larkin RESPIRONICS, INC. 1740 GOLDEN MILE HIGHWAY Monroeville, PA 15146 |
| Product Code | MOD |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-20 |
| Decision Date | 2017-02-17 |
| Summary: | summary |