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 | K183704 |
| 510k Number | K183704 |
| Device Name: | RX-1 Rhythm Express Remote Cardiac Monitoring System |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | VivaQuant Inc. 4339 Nancy Place, Suite 100 St. Paul, MN 55126 |
| Contact | Brian Brockway |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2018-12-31 |
| Decision Date | 2019-02-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860000272414 | K183704 | 000 |
| 00860000272407 | K183704 | 000 |