The following data is part of a premarket notification filed by Avicena Llc with the FDA for Vivio System.
| Device ID | K183710 |
| 510k Number | K183710 |
| Device Name: | Vivio System |
| Classification | Stethoscope, Electronic |
| Applicant | Avicena LLC 2400 Lincoln Ave, Suite 213 Altadena, CA 91001 |
| Contact | Sean Brady |
| Correspondent | James West West Device Innovations 23412 West 46th Street Shawnee, KS 66226 |
| Product Code | DQD |
| CFR Regulation Number | 870.1875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-31 |
| Decision Date | 2019-10-04 |