K052811 is an FDA 510(k) clearance for the HSINER JET NEBULIZER, MODEL HS-31100. 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 December 21, 2005, 78 days after receiving the submission on October 4, 2005.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5630.
| 510(k) Number | K052811 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 04, 2005 |
| Decision Date | December 21, 2005 |
| Days to Decision | 78 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 |