510(k) K123195 ยท CCL Analyzer, Gas, Oxygen, Gaseous-Phase
CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIES
| Applicant | GE Healthcare Finland Oy, Helsinki, FI |
| Decision | Substantially Equivalent, Feb 28, 2013 |
| Received | Oct 11, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123195
| 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-sCAiO Terminated |
CCK | None listed |
| Jan 10, 2020 | GE Healthcare, LLC CARESCAPE Respiratory Module E-sCAiOV Terminated |
CCK | None listed |
| Sep 9, 2014 | GE Healthcare, LLC CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE; the Airway Gas Option N-CAiO and respective service exchange units.
The affected modules could be in use with any Terminated |
CCL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.