The following data is part of a premarket notification filed by Alivecor, Inc. with the FDA for Kardiamobile 6l.
| Device ID | K210753 |
| 510k Number | K210753 |
| Device Name: | KardiaMobile 6L |
| Classification | Electrocardiograph |
| Applicant | AliveCor, Inc. 444 Castro Street, Suite 600 Mountain View, CA 94041 |
| Contact | Saket Bhatt |
| Correspondent | Prabhu Raghavan MDQR, LLC 444 Castro Street, Suite 600 Mountain View, CA 94041 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-15 |
| Decision Date | 2021-06-30 |