The following data is part of a premarket notification filed by Shining World Health Care Co., Ltd. with the FDA for Shinmed Model Sw-966 Ultrasonic Nebulizer.
| Device ID | K980024 |
| 510k Number | K980024 |
| Device Name: | SHINMED MODEL SW-966 ULTRASONIC NEBULIZER |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | SHINING WORLD HEALTH CARE CO., LTD. 6F, NO. 8, LANE 7, WU-CHUN RD. WU-KU INDUSTRIAL PARK Taipei Hsien, TW 24886 |
| Contact | Carolann Kotula |
| Correspondent | Carolann Kotula SHINING WORLD HEALTH CARE CO., LTD. 6F, NO. 8, LANE 7, WU-CHUN RD. WU-KU INDUSTRIAL PARK Taipei Hsien, TW 24886 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-05 |
| Decision Date | 1999-09-03 |
| Summary: | summary |