K200695 is an FDA 510(k) clearance for the MATRx plus. This device is classified as a Ventilatory Effort Recorder (Class II - Special Controls, product code MNR).
Submitted by Zephyr Sleep Technologies (Calgary, CA). The FDA issued a Cleared decision on August 24, 2020, 160 days after receiving the submission on March 17, 2020.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 868.2375.
| 510(k) Number | K200695 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 17, 2020 |
| Decision Date | August 24, 2020 |
| Days to Decision | 160 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | MNR - Ventilatory Effort Recorder |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.2375 |