510(k) K935655 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
ABL5 BLOOD GAS SYSTEM
| Applicant | Radiometer America, Inc., Westlake OH, US |
| Decision | Substantially Equivalent, May 27, 1994 |
| Received | Nov 24, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K935655
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 10, 2014 | Radiometer America Inc pO2 D999 membrane units. Distributed by Radiometer America, Inc., Westlake, OH 44145
pO2 membrane units, ordering number 942-042 Intended use is in vitro testing of samples of whole blood for pO2 (par Terminated |
CHL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.