K183710 is an FDA 510(k) clearance for the Vivio System. This device is classified as a Stethoscope, Electronic (Class II - Special Controls, product code DQD).
Submitted by Avicena, LLC (Altadena, US). The FDA issued a Cleared decision on October 4, 2019, 277 days after receiving the submission on December 31, 2018.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1875.
| 510(k) Number | K183710 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 31, 2018 |
| Decision Date | October 04, 2019 |
| Days to Decision | 277 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQD - Stethoscope, Electronic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1875 |