The following data is part of a premarket notification filed by Suzhou Weikang Medical Apparatus Co., Ltd with the FDA for Disposable Nebulizer Set.
| Device ID | K140237 |
| 510k Number | K140237 |
| Device Name: | DISPOSABLE NEBULIZER SET |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | SUZHOU WEIKANG MEDICAL APPARATUS CO., LTD 7TH FL. JINGUI BUSINESS BUIDLING NO. 982 CONGYUN RD, BAIYUN DISTRICT Guangzhou, Guangdong, CN 510420 |
| Contact | Mike Gu |
| Correspondent | Mike Gu SUZHOU WEIKANG MEDICAL APPARATUS CO., LTD 7TH FL. JINGUI BUSINESS BUIDLING NO. 982 CONGYUN RD, BAIYUN DISTRICT Guangzhou, Guangdong, CN 510420 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-30 |
| Decision Date | 2015-01-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40612479231670 | K140237 | 000 |
| 00616784560731 | K140237 | 000 |
| 00616784561738 | K140237 | 000 |
| 10850005165108 | K140237 | 000 |
| 10850005165092 | K140237 | 000 |
| 10850005165085 | K140237 | 000 |
| 10850005165078 | K140237 | 000 |