The following data is part of a premarket notification filed by Vivaquant Inc. with the FDA for Rx-1 Rhythm Express Remote Cardiac Monitoring System.
| Device ID | K200833 |
| 510k Number | K200833 |
| Device Name: | RX-1 Rhythm Express Remote Cardiac Monitoring System |
| Classification | Electrocardiograph, Ambulatory, With Analysis Algorithm |
| Applicant | VivaQuant Inc. 4339 Nancy Place, Suite 100 St. Paul, MN 55126 |
| Contact | Brian Brockway |
| Correspondent | Brodie Pedersen Borderless Compliance, LLC 7118 Teakwood Cir Maple Grove, MN 55369 |
| Product Code | MLO |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-30 |
| Decision Date | 2020-09-02 |