510(k) K923024 ยท CAF Nebulizer (Direct Patient Interface)
NE-U04/NE U04F
| Applicant | Omron Healthcare, Inc., Vernon Hills IL, US |
| Decision | Substantially Equivalent, Sep 15, 1992 |
| Received | Jun 23, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K923024
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 5, 2005 | Omron Healthcare, Inc. Medication Bottle (U22-3), a component of the MicroAir Vibrating Mesh Nebulizer, Model NE-U22V/NE-22VAC; Distributed by: Omron Healthcare, Inc., 300 Lakeview Parkway, Vernon Hills, IL 60061 Terminated |
CAF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.