510(k) K954612 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
ABL SYSTEM 625, 615, 605
| Applicant | Radiometer America, Inc., Westlake OH, US |
| Decision | Substantially Equivalent, Nov 9, 1995 |
| Received | Oct 5, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954612
| 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.