510(k) K960817 ยท MQS System, Hemodialysis, Access Recirculation Monitoring
HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2)
| Applicant | Transonic Systems, Inc., Ithaca NY, US |
| Decision | Substantially Equivalent, Feb 11, 1997 |
| Received | Feb 28, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K960817
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 18, 2015 | Transonic Systems Inc Transonic Hemodialysis Monitor, Model HD03 --
Product Usage: The Hemodialysis Monitor is intended for use by trained medical personnel to measure delivered blood flow, vascular access recirculat Terminated |
MQS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.