The following data is part of a premarket notification filed by Cordiana Medical Informatics Ag with the FDA for Cordiana Dx16.
| Device ID | K201060 |
| 510k Number | K201060 |
| Device Name: | Cordiana Dx16 |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | Cordiana Medical Informatics AG Platz 4 Root, CH 6039 |
| Contact | Johan Sandberg |
| Correspondent | Johan Sandberg Cordiana Medical Informatics AG Platz 4 Root, CH 6039 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-21 |
| Decision Date | 2020-11-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07649988821110 | K201060 | 000 |