K161411 is an FDA 510(k) clearance for the Care Cycle Connect Application. This device is classified as a Accessory To Continuous Ventilator (respirator) (Class II - Special Controls, product code MOD).
Submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on February 17, 2017, 273 days after receiving the submission on May 20, 2016.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5895.
| 510(k) Number | K161411 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 20, 2016 |
| Decision Date | February 17, 2017 |
| Days to Decision | 273 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | MOD — Accessory To Continuous Ventilator (respirator) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5895 |