510(k) K961476 ยท CAF Nebulizer (Direct Patient Interface)
SALTERLABS 8960 SERIES NEBULIZER (8960/8961/8966/8984)
| Applicant | Salter Labs, Arvin CA, US |
| Decision | Substantially Equivalent, Jul 16, 1996 |
| Received | Apr 18, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961476
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 17, 2015 | Salter Labs NebuTech Nebulizer, Model number: Series 8660, 8960, 8961, 8966, 8984. Nebulizer used to generate aerosols delivered directly to the patient for breathing. Designed to be used in either a hospital or Terminated |
CAF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.