510(k) K870051 ยท CAF Nebulizer (Direct Patient Interface)
SPAG-2 AEROSOL GENERATOR W/USE OF VIRAZOLE
| Applicant | Viratek, Inc., Costa Mesa CA, US |
| Decision | Substantially Equivalent, Oct 6, 1987 |
| Received | Jan 6, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K870051
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 21, 2016 | Valeant Pharmacueticals International Valeant Pharmaceuticals North America, Small Particle Size Aerosol Generator, SPAG-2 6000 series. Model No. SPAG-2. A nebulizer pneumatic flow system for the administration of Virazole (ribavirin) a Terminated |
CAF | None listed |
| Dec 4, 2015 | Valeant Pharmaceuticals North America LLC Valeant Pharmaceuticals North America Model No. Spag-2
Small Particle Size Aerosol Generator SPAG-2 6000 is a pneumatic flow system indicated for the administration of Viazole uses a nebulizer to gene Terminated |
CAF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.