K193586 is an FDA 510(k) clearance for the Vivo 45 LS. This device is classified as a Continuous, Ventilator, Home Use (Class II - Special Controls, product code NOU).
Submitted by Breas Medical AB (Molnlycke, SE). The FDA issued a Cleared decision on January 27, 2021, 401 days after receiving the submission on December 23, 2019.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5895. This Product Code Was Needed For The Home Use Indication. Cbk Is Not A Tracked Device And Nou Is A Tracked Device..
| 510(k) Number | K193586 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 2019 |
| Decision Date | January 27, 2021 |
| Days to Decision | 401 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | NOU — Continuous, Ventilator, Home Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5895 |
| Definition | This Product Code Was Needed For The Home Use Indication. Cbk Is Not A Tracked Device And Nou Is A Tracked Device. |