K031370 is an FDA 510(k) clearance for the SHINMED MODE SW-988 UNTRASONIC NEBULIZER. This device is classified as a Nebulizer (direct Patient Interface) (Class II - Special Controls, product code CAF).
Submitted by Shining World Health Care Co., Ltd. (Hsin Chu City, TW). The FDA issued a Cleared decision on September 1, 2004, 490 days after receiving the submission on April 30, 2003.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5630.
| 510(k) Number | K031370 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 30, 2003 |
| Decision Date | September 01, 2004 |
| Days to Decision | 490 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | CAF - Nebulizer (direct Patient Interface) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5630 |