510(k) K982928 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM
| Applicant | Radiometer America, Inc., Westlake OH, US |
| Decision | Substantially Equivalent, Jan 6, 1999 |
| Received | Aug 20, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982928
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 26, 2006 | Radiometer America Inc D7120, BG-OX Cartridge, D7120 REF 946-003, and 946-001, cuvettes for the NPT7 series of blood gas analyzers. Terminated |
CHL | None listed |
| Jul 27, 2006 | Radiometer America Inc Dri-Tek BG-OX Cartridge, Model #D7120, Cat. #946-003 Cartridges used in the NPT7 Analyzer, an in vitro diagnostic device. Terminated |
CHL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.