510(k) K140062 ยท NVP Holding Chambers, Direct Patient Interface
FSC ANTI-STATIC VALVED COLLAPSIBLE HOLDING CHAMBER
| Applicant | Fsc Laboratories, Inc., Charlotte NC, US |
| Decision | Substantially Equivalent, Oct 3, 2014 |
| Received | Jan 10, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140062
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 15, 2016 | FSC Laboratories, Inc Flexichamber Anti-Static Valved Collapsible Holding Chamber, used by patients to administer aerosolized medication from most pressurized Metered Dose Inhalers(pMDIs). Terminated |
NVP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.