510(k) K884947 ยท CAF Nebulizer (Direct Patient Interface)
HAND HELD NEBULIZER SYSTEM
| Applicant | Salter Labs, Arvin CA, US |
| Decision | Substantially Equivalent, Feb 17, 1989 |
| Received | Nov 25, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K884947
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 10, 2016 | Salter Labs T-piece Nebulizer with in-line connectors, Part number 8915-7-50. Single patient use, non-sterile prescription device designed for use in a hospital or home care environment. Terminated |
CAF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.