510(k) K091272 ยท CAF Nebulizer (Direct Patient Interface)
BESMED JET NEBULIZER BOTTLE SET
| Applicant | Besmed Health Business Corp, Hsin Chu City, TW |
| Decision | Substantially Equivalent, Nov 10, 2009 |
| Received | Apr 30, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091272
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 29, 2018 | SANRAI INTERNATIONAL LLC Sunset Compressor Nebulizer, Model NEB100 - Product Usage: The Sunset Compressor Nebulizer is an AC-powered air nebulizer compressor system intended to provide a source of compressed air for medical p Terminated |
CAF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.