The following data is part of a premarket notification filed by Livmor with the FDA for Halo Af Detection System.
| Device ID | K201208 |
| 510k Number | K201208 |
| Device Name: | Halo AF Detection System |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | LIVMOR 16470 Bake Pkwy., Ste. 200 Irvine, CA 92618 |
| Contact | Ken Persen |
| Correspondent | Ken Persen LIVMOR 16470 Bake Pkwy., Ste. 200 Irvine, CA 92618 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-05 |
| Decision Date | 2020-09-23 |