510(k) K831506 ยท DRS Transducer, Blood-Pressure, Extravascular
DISP. TRANSDUCER W/MONITORING KIT TRANS
| Applicant | Sorensen Research, Walker MI, US |
| Decision | Substantially Equivalent, Aug 12, 1983 |
| Received | May 11, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K831506
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 27, 2018 | ICU Medical, Inc. ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing, Disposable Transducer, 3 ml Intraflo Flush, Macrodrip (Pole Mount), REF: 42641-06, Sterile EO Terminated |
DRS | None listed |
| Feb 8, 2006 | Hospira Inc. Hospira Transpac IV Monitoring Kit, 60 inch disposable transducer monitoring kit with second stopcock by transducer, continuous flush device and drip chamber; Made in Costa Rica, Hospira, Inc., Lake F Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.