The following data is part of a premarket notification filed by Alivecor, Inc. with the FDA for Kardiaai.
| Device ID | K181823 |
| 510k Number | K181823 |
| Device Name: | KardiaAI |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | AliveCor, Inc. 444 Castro Street, Suite 600 Mountain View, CA 94041 |
| Contact | Prabhu Raghavan |
| Correspondent | Prabhu Raghavan AliveCor, Inc. 444 Castro Street, Suite 600 Mountain View, CA 94041 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-09 |
| Decision Date | 2019-03-11 |