K200063 is an FDA 510(k) clearance for the AeroEclipse* ONE BAN. This device is classified as a Nebulizer (direct Patient Interface) (Class II - Special Controls, product code CAF).
Submitted by Trudell Medical International (London, CA). The FDA issued a Cleared decision on July 17, 2020, 186 days after receiving the submission on January 13, 2020.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5630.
| 510(k) Number | K200063 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 13, 2020 |
| Decision Date | July 17, 2020 |
| Days to Decision | 186 days |
| Submission Type | Abbreviated |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CAF - Nebulizer (direct Patient Interface) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5630 |