The following data is part of a premarket notification filed by Alivecor, Inc. with the FDA for Kardiamobile Card.
| Device ID | K211668 |
| 510k Number | K211668 |
| Device Name: | KardiaMobile Card |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | AliveCor, Inc. 444 Castro Street, Suite 600 Mountain View, CA 94041 |
| Contact | Saket Bhatt |
| Correspondent | Shani Frenkel AliveCor, Inc. 444 Castro Street, Suite 600 Mountain View, CA 94041 |
| Product Code | DXH |
| Subsequent Product Code | DPS |
| Subsequent Product Code | QDA |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-01 |
| Decision Date | 2021-11-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B210AC0210 | K211668 | 000 |