K140880 is an FDA 510(k) clearance for the DEVILBISS SMARTLINK II SYSTEM. This device is classified as a Ventilator, Non-continuous (respirator) (Class II - Special Controls, product code BZD).
Submitted by Devilbiss Healthcare, LLC (Somerset, US). The FDA issued a Cleared decision on August 4, 2014, 119 days after receiving the submission on April 7, 2014.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5905.
| 510(k) Number | K140880 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 07, 2014 |
| Decision Date | August 04, 2014 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BZD - Ventilator, Non-continuous (respirator) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5905 |