The following data is part of a premarket notification filed by Shining World Health Care Co., Ltd. with the FDA for Shinmed Mode Sw-988 Untrasonic Nebulizer.
| Device ID | K031370 |
| 510k Number | K031370 |
| Device Name: | SHINMED MODE SW-988 UNTRASONIC NEBULIZER |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | SHINING WORLD HEALTH CARE CO., LTD. NO. 58, FU-CHIUN ST. Hsin-chu City, TW 300 |
| Contact | Jen Ke-min |
| Correspondent | Jen Ke-min SHINING WORLD HEALTH CARE CO., LTD. NO. 58, FU-CHIUN ST. Hsin-chu City, TW 300 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-30 |
| Decision Date | 2004-09-01 |