K070411 is an FDA 510(k) clearance for the AMSURE NEBULIZER. This device is classified as a Nebulizer (direct Patient Interface) (Class II - Special Controls, product code CAF).
Submitted by Amsino International, Inc. (Pomona, US). The FDA issued a Cleared decision on October 1, 2007, 231 days after receiving the submission on February 12, 2007.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5630.
| 510(k) Number | K070411 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 12, 2007 |
| Decision Date | October 01, 2007 |
| Days to Decision | 231 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 |