510(k) K192633 ยท CAF Nebulizer (Direct Patient Interface)
GUS831 Compressor Nebulizer
| Applicant | Globalcare Medical Technology Co., Ltd., Xiaolan Town, Zhongshan City, CN |
| Decision | Substantially Equivalent, May 1, 2020 |
| Received | Sep 23, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192633
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.