The following data is part of a premarket notification filed by Cathvision Aps with the FDA for Ecgenius System.
| Device ID | K220306 |
| 510k Number | K220306 |
| Device Name: | ECGenius System |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | CathVision ApS Titangade 11 Copenhagen N, DK 2200 |
| Contact | Mads Matthiesen |
| Correspondent | Sharon Bishop Graematter, Inc. 1324 Clarkson Clayton Ctr #332 St. Louis, MO 63011 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-02 |
| Decision Date | 2022-05-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05700002168528 | K220306 | 000 |