510(k) K961404 ยท DRS Transducer, Blood-Pressure, Extravascular
MX960 REUSABLE PRESSURE TRANSDUCER
| Applicant | Medex, Inc., Dublin OH, US |
| Decision | Substantially Equivalent, Jun 27, 1996 |
| Received | Apr 11, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961404
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 21, 2021 | Smiths Medical ASD Inc. LogiCal Monitoring Set, Model Number DPS564898. for blood pressure monitoring and blood sampling. Terminated |
DRS | None listed |
| Apr 21, 2021 | Smiths Medical ASD Inc. Mark 910 LogiCal, Model Number DPS567201. for blood pressure monitoring and blood sampling. Terminated |
DRS | None listed |
| Apr 21, 2021 | Smiths Medical ASD Inc. LogiCal Left Heart Kit, Model Number M20553. for blood pressure monitoring. Terminated |
DRS | None listed |
| Apr 21, 2021 | Smiths Medical ASD Inc. Gang Cath Lab Set, Model Number M20858R1.for the administration of IV fluids. Stopcocks and manifolds are used to control the direction of IV fluid flow. Terminated |
FPB | None listed |
| Apr 21, 2021 | Smiths Medical ASD Inc. Stopcock rotator (Component):
a. 1050 STOPCOCK ROTATOR, OFF HANDLE, Model Number MX1431MR
b. 1050 STOPCOCK LEFT ROTATOR, OFF HANDLE, Model Number MX1431MRL
c. 700 PSI STPCK W/ ROTATOR, Model Number MX Terminated |
DRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.