510(k) K052743 ยท CBP Valve, Non-Rebreathing
DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921
| Applicant | Dynarex Corp., Orangeburg NY, US |
| Decision | Substantially Equivalent, Dec 22, 2005 |
| Received | Sep 30, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052743
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 25, 2014 | Dynarex Corporation CPR Shield With One Way Valve and Barrier Filter, Reorder No. 4921 --- Dynarex label, 100 per case --- Manufactured for: Dynarex Corporation - Made in China.
Used as a physical barrier for mouth to m Terminated |
CBP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.