510(k) K201397 ยท CAF Nebulizer (Direct Patient Interface)
Ultrasonic Mesh Nebulizer
| Applicant | Shenzhen Ivankaca Technology Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Jun 14, 2021 |
| Received | May 28, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201397
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.