510(k) K945240 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
IRMA BLOOD ANALYSIS SYSTEM
| Applicant | Diametrics Medical, Inc., Roseville MN, US |
| Decision | Substantially Equivalent, Jan 5, 1995 |
| Received | Oct 27, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945240
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 23, 2015 | LifeHealth, LLC CC cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 039903.
The CC Cartridge are single use, disposable, in vitro diagnostics intended for point of care (POC), professional, use with the IRMA TRUpo Terminated |
CHL | None listed |
| Oct 23, 2015 | LifeHealth, LLC BG cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 048103.
BG Cartridge are single use, disposable, in vitro diagnostics intended for point of care (POC), professional, use with the IRMA TRUpoin Terminated |
CHL | None listed |
| Jun 27, 2015 | LifeHealth, LLC LifeHealth, IRMA TRUPOINT model 443914, typically used in point-of-care settings. For the in vitro measurement of various critical care analytes in human whole blood. These analytes includes: pO2, Terminated |
CHL | None listed |
| Jul 30, 2003 | Diametrics Medical, Inc. IRMA SL Blood Analysis System CC pH, pCO2, pO2, Hct, Na+, K+, iCa Cartridge, Part Number 039903(M3586A). There are 25 disposable cartridges in a box of IRMA SL Blood Analysis System CC pH, pCO2, pO2, Terminated |
JJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.