K231005 is an FDA 510(k) clearance for the Aurelia Surgical Mask ASTM Level 1. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Supermax Healthcare Canada-Supermax Medical (Saint-Bruno-De-Montarville, CA). The FDA issued a Cleared decision on December 5, 2023, 242 days after receiving the submission on April 7, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K231005 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 07, 2023 |
| Decision Date | December 05, 2023 |
| Days to Decision | 242 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FXX - Mask, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |