The following data is part of a premarket notification filed by Ecordum, Inc. with the FDA for Ecordum Cardiac Monitor (ecordum Cm).
| Device ID | K193296 |
| 510k Number | K193296 |
| Device Name: | ECordum Cardiac Monitor (eCordum CM) |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | eCordum, Inc. 419 1st Street East Northport, NY 11731 |
| Contact | Vladislav Bukhman |
| Correspondent | Becky Ditty Biologics Consulting 1555 King St, Suite 300 Alexandria, VA 22314 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-27 |
| Decision Date | 2020-10-30 |