510(k) K980130 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM
| Applicant | Radiometer America, Inc., Westlake OH, US |
| Decision | Substantially Equivalent, Feb 9, 1998 |
| Received | Jan 14, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980130
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 24, 2014 | Radiometer America Inc pCO2 D788 Membranes. Distributed by Radiometer America, Inc., Westlake, OH.
An automatic or semi-automatic instrument used to identify and quantify two or more gases, and sometimes electrolytes, in w Terminated |
CHL | None listed |
| 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 |
| Aug 10, 2006 | Radiometer America Inc Blood Gas and Co-Ox2 Electrolyte & Metabolyte Analyzers, ABL-700 Series, manufactured from 8/1998 through 11/2004. Terminated |
JFP | None listed |
| Aug 3, 2006 | Radiometer America Inc Reference Electrodes for ABL 700/800 Blood Gas Analyzers. Electrode Part Number: 945-603, distributed one (1) electrode per box. Terminated |
CHL | None listed |
| Aug 1, 2006 | Radiometer America Inc D 744 Chloride membrane, CI, REF Model #942-061, accessory to the ABL700 blood analyzer. Terminated |
CGZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.