510(k) K063526 ยท CAH Filter, Bacterial, Breathing-Circuit
A-M SYSTEMS VIROMAX VIRAL AND BACTERIAL FILTER
| Applicant | A-M Systems, Inc., Roswell GA, US |
| Decision | Substantially Equivalent, Jun 29, 2007 |
| Received | Nov 22, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063526
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2012 | A M Systems Inc ViroMax viral/bacterial filter. The filter reduces the risk of infection due to cross-contamination between patients
For use on all patient populations in conjunction with other respiratory devices co Terminated |
CAH | None listed |
| Jun 3, 2010 | Continental Medical Labs,Inc Xenon Diagnostic Circuit Kits labeled as "Xenon Diagnostic Circuit", "Xenon Circuit", and Needleless Xenon Diagnostic Circuit" Manufactured for RAF MEDICAL, INC., (Model number's RAF2306, RAF2304, RA Terminated |
CAH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.