K171827 is an FDA 510(k) clearance for the ReddyPort NIV Access Elbow. This device is classified as a Ventilator, Continuous, Non-life-supporting (Class II - Special Controls, product code MNS).
Submitted by Smd Manufacturing, LLC (Salt Lake City, US). The FDA issued a Cleared decision on January 19, 2018, 213 days after receiving the submission on June 20, 2017.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5895.
| 510(k) Number | K171827 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 20, 2017 |
| Decision Date | January 19, 2018 |
| Days to Decision | 213 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | MNS - Ventilator, Continuous, Non-life-supporting |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5895 |