510(k) K943882 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
ABL5 BLOOD GAS SYSTEM;BPH5 BLOOD PH SYSTEM
| Applicant | Radiometer America, Inc., Westlake OH, US |
| Decision | Substantially Equivalent, Mar 10, 1995 |
| Received | Aug 9, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943882
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 3, 2006 | Radiometer America Inc ABL 5 Capillary Adaptor (a connection that fits the capillary tube on to the aspirator on the ABL 5 & BPH 5 Analyzers), in vitro diagnostic accessory, Part Number: 906-018. Terminated |
CHL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.