K182394 is an FDA 510(k) clearance for the WiZARD 310/320 Series CPAP Mask. This device is classified as a Ventilator, Non-continuous (respirator) (Class II - Special Controls, product code BZD).
Submitted by Apex Medical Corp. (New Taipei City, TW). The FDA issued a Cleared decision on May 17, 2019, 255 days after receiving the submission on September 4, 2018.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5905.
| 510(k) Number | K182394 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 04, 2018 |
| Decision Date | May 17, 2019 |
| Days to Decision | 255 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 |