Acutus Medical, Inc. · Class II · Cleared Jan 17, 2020
| K-number | K193509 |
| Device name | AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX |
| Applicant | Acutus Medical, Inc. |
| Product code | DYB |
| Device class | Class II |
| Decision date | Jan 17, 2020 |
| Decision | Substantially Equivalent |
| Regulation | 870.1340 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov