K151361 is an FDA 510(k) clearance for the Nox RIP Belts & Cables. This device is classified as a Ventilatory Effort Recorder (Class II - Special Controls, product code MNR).
Submitted by Nox Medical Ehf (Reykjavik, IS). The FDA issued a Cleared decision on November 6, 2015, 169 days after receiving the submission on May 21, 2015.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2375.
| 510(k) Number | K151361 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 21, 2015 |
| Decision Date | November 06, 2015 |
| Days to Decision | 169 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | MNR — Ventilatory Effort Recorder |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.2375 |