The following data is part of a premarket notification filed by Globalcare Medical Technology Co., Ltd. with the FDA for Gus831 Compressor Nebulizer.
| Device ID | K192633 |
| 510k Number | K192633 |
| Device Name: | GUS831 Compressor Nebulizer |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | Globalcare Medical Technology Co., Ltd. 7th Building, 39 Middle Industrial Main Road, European Industrial Zone Xiaolan Town, Zhongshan City, CN 528415 |
| Contact | Janice Deng |
| Correspondent | Kevin Wang Chonconn Medical Device Consulting Co., Ltd. No. A415, Block A, Nanshan Medical Device Industrial Park, Nanshan District Shenzhen, CN 518067 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-23 |
| Decision Date | 2020-05-01 |