K200654 is an FDA 510(k) clearance for the Rubicon SA System. This device is classified as a Ventilatory Effort Recorder (Class II - Special Controls, product code MNR).
Submitted by Dymedix Diagnostics, Inc. (Shoreview, US). The FDA issued a Cleared decision on July 22, 2020, 132 days after receiving the submission on March 12, 2020.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2375.
| 510(k) Number | K200654 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 12, 2020 |
| Decision Date | July 22, 2020 |
| Days to Decision | 132 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 |