K063716 is an FDA 510(k) clearance for the AEROSOL SYSTEM. This device is classified as a Nebulizer (direct Patient Interface) (Class II - Special Controls, product code CAF).
Submitted by Amici, Inc. (Spring City, US). The FDA issued a Cleared decision on December 28, 2007, 379 days after receiving the submission on December 14, 2006.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5630.
| 510(k) Number | K063716 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 14, 2006 |
| Decision Date | December 28, 2007 |
| Days to Decision | 379 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 |