K202096 is an FDA 510(k) clearance for the 3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Ecoguard, Inc. (Grover, US). The FDA issued a Cleared decision on February 2, 2021, 188 days after receiving the submission on July 29, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K202096 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 29, 2020 |
| Decision Date | February 02, 2021 |
| Days to Decision | 188 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 |