K203601 is an FDA 510(k) clearance for the Innova Nasal Non-Vented Mask. This device is classified as a Ventilator, Non-continuous (respirator) (Class II - Special Controls, product code BZD).
Submitted by Sleepnet Corporation (Hampton, US). The FDA issued a Cleared decision on April 30, 2021, 142 days after receiving the submission on December 9, 2020.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5905.
| 510(k) Number | K203601 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 09, 2020 |
| Decision Date | April 30, 2021 |
| Days to Decision | 142 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 |