The following data is part of a premarket notification filed by Acutus Medical, Inc. with the FDA for Acqmap High Resolution Imaging And Mapping System.
| Device ID | K190131 |
| 510k Number | K190131 |
| Device Name: | AcQMap High Resolution Imaging And Mapping System |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | Acutus Medical, Inc. 2210 Faraday Ave., Suite 100 Carlsbad, CA 92008 |
| Contact | Serena Sanginthirath |
| Correspondent | Serena Sanginthirath Acutus Medical, Inc. 2210 Faraday Ave., Suite 100 Carlsbad, CA 92008 |
| Product Code | DQK |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-28 |
| Decision Date | 2019-04-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857042007210 | K190131 | 000 |
| 00857042007241 | K190131 | 000 |
| 00857042007258 | K190131 | 000 |
| 00857042007265 | K190131 | 000 |
| 00857042007272 | K190131 | 000 |
| 00857042007289 | K190131 | 000 |
| 00857042007296 | K190131 | 000 |
| 00857042007302 | K190131 | 000 |
| 00857042007319 | K190131 | 000 |
| 00857042007326 | K190131 | 000 |
| 00857042007234 | K190131 | 000 |