510(k) K130144 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
ABL90 FLEX
| Applicant | Radiometer Medical Aps, Bronshoj, DK |
| Decision | Substantially Equivalent, Jul 31, 2013 |
| Received | Jan 22, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K130144
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 14, 2018 | Radiometer Medical ApS AQURE, Software version 2.3.0 and 2.3.1
Product Usage:
The AQURE system is intended to let allow the management of analytical devices and operator profiles. The user can associate patient data with t Terminated |
CHL | None listed |
| Dec 22, 2016 | Radiometer America Inc AQURE System
Software Version 2.2.0
Model #: 933-599
UDI: (01)05700699335999(10)2.2.0
Catalog number: 933-599
The AQURE system manages Radiometer blood gas and immunoassay analyzers and results from Terminated |
CHL | None listed |
| Feb 3, 2016 | Radiometer America Inc AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay analyzers. Terminated |
CHL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.