The following data is part of a premarket notification filed by Excellentcare Medical (huizhou) Ltd. with the FDA for Nebulizer Kit.
| Device ID | K192971 |
| 510k Number | K192971 |
| Device Name: | Nebulizer Kit |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | Excellentcare Medical (Huizhou) Ltd. Shatou Industrial Zone. Yuanzhou Town. Huizhou, CN 516123 |
| Contact | Chunyu Zhao |
| Correspondent | Elly Xu Shenzhen Joyantech Consulting Co., Ltd. NO. 55 Shizhou Middle Road, Nanshan District Shenzhen, CN 518000 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-23 |
| Decision Date | 2021-07-08 |