The following data is part of a premarket notification filed by Alivecor, Inc with the FDA for Kardia Band System.
| Device ID | K171816 |
| 510k Number | K171816 |
| Device Name: | Kardia Band System |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | AliveCor, Inc 444 Castro Street, Suite 600 Mountain View, CA 94041 |
| Contact | Prabhu Raghavan |
| Correspondent | Anna Libman Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose, CA 95110 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-19 |
| Decision Date | 2017-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B210AC0110 | K171816 | 000 |