510(k) K160153 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
ABL90 FLEX PLUS
| Applicant | Radiometer Medical Aps, Broenshoej, DK |
| Decision | Substantially Equivalent, Nov 4, 2016 |
| Received | Jan 22, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K160153
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 23, 2025 | Radiometer Medical ApS Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090
Radiometer ABL90 Series - Radiometer ABL90 FLEX PLUS Model Number 393-092
The Radiometer ABL90 Series is a portable, automated an Open, Classified |
CHL | None listed |
| Apr 14, 2021 | Radiometer Medical ApS Radiometer ABL90 FLEX PLUS Analyzer with E3800 PC units.
The E3800 CPU is also used as spare part. Open, Classified |
CHL | None listed |
| Apr 14, 2021 | Radiometer Medical ApS E3800 PC Units (spare parts) Open, Classified |
CEM | None listed |
| Feb 3, 2020 | Radiometer Medical ApS ABL90 FLEX PLUS Analyzer, Model Number 393-092 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting. Terminated |
CHL | None listed |
| Nov 21, 2019 | Radiometer Medical ApS ABL90 FLEX PLUS, model no. 393-02; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are intended for use by trained technologists, nurses, physicians and therapists. It is inte Terminated |
CHL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.