K160481 is an FDA 510(k) clearance for the Vivo 60. This device is classified as a Continuous, Ventilator, Home Use (Class II - Special Controls, product code NOU).
Submitted by Breas Medical AB (Molnlycke Vastra Gotalands Lan, SE). The FDA issued a Cleared decision on November 9, 2016, 261 days after receiving the submission on February 22, 2016.
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 | K160481 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 22, 2016 |
| Decision Date | November 09, 2016 |
| Days to Decision | 261 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. |