510(k) K171028 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessories
| Applicant | GE Healthcare Finland Oy, Helsinki, FI |
| Decision | Substantially Equivalent, Aug 17, 2017 |
| Received | Apr 5, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171028
| 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.