K183586 is an FDA 510(k) clearance for the CapMedic. This device is classified as a Nebulizer (direct Patient Interface) (Class II - Special Controls, product code CAF).
Submitted by Cognita Labs, LLC (Santa Ana, US). The FDA issued a Cleared decision on September 13, 2019, 266 days after receiving the submission on December 21, 2018.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5630.
| 510(k) Number | K183586 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 2018 |
| Decision Date | September 13, 2019 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| 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 |