K082009 is an FDA 510(k) clearance for the HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS. This device is classified as a Nebulizer (direct Patient Interface) (Class II - Special Controls, product code CAF).
Submitted by Hsiner Co., Ltd. (Temecula, US). The FDA issued a Cleared decision on August 22, 2008, 30 days after receiving the submission on July 23, 2008.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5630.
| 510(k) Number | K082009 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 23, 2008 |
| Decision Date | August 22, 2008 |
| Days to Decision | 30 days |
| Submission Type | Special |
| 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 |