510(k) K183394 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO
| Applicant | GE Healthcare Finland Oy, Helsinki, FI |
| Decision | Substantially Equivalent, May 1, 2019 |
| Received | Dec 7, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K183394
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 10, 2020 | GE Healthcare, LLC CARESCAPE Respiratory Module E-sCO Terminated |
CCK | None listed |
| Jan 10, 2020 | GE Healthcare, LLC CARESCAPE Respiratory Module E-sCOVX Terminated |
CCK | None listed |
| Jan 10, 2020 | GE Healthcare, LLC CARESCAPE Respiratory Module E-sCAiO Terminated |
CCK | None listed |
| Jan 10, 2020 | GE Healthcare, LLC CARESCAPE Respiratory Module E-sCAiOV Terminated |
CCK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.