K200833 is an FDA 510(k) clearance for the RX-1 Rhythm Express Remote Cardiac Monitoring System. This device is classified as a Electrocardiograph, Ambulatory, With Analysis Algorithm (Class II - Special Controls, product code MLO).
Submitted by Vivaquant, Inc. (St. Paul, US). The FDA issued a Cleared decision on September 2, 2020, 156 days after receiving the submission on March 30, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2800.
| 510(k) Number | K200833 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 30, 2020 |
| Decision Date | September 02, 2020 |
| Days to Decision | 156 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MLO - Electrocardiograph, Ambulatory, With Analysis Algorithm |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2800 |