510(k) K914166 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
ABL505 BLOOD GAS & ELECTROLYTE SYSTEM
| Applicant | Radiometer America, Inc., Westlake OH, US |
| Decision | Substantially Equivalent, Jan 28, 1992 |
| Received | Sep 17, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K914166
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 16, 2011 | Radiometer America Inc Ca++ Membrane Units, Model #942-046, and Model #942-060 used on ABL505/555, EML105, ABL600, ABL700 Series, and ABL800 Analyzers. The membranes are packaged in a plastic box which contains four (4) me Terminated |
JFP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.