510(k) K163381 ยท DQK Computer, Diagnostic, Programmable
HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Apr 14, 2017 |
| Received | Dec 1, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163381
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 8, 2020 | Edwards Lifesciences, LLC Oxymetry Cable, Rxonly. REF/UDI: HEMOXSC100/(01)00690103196986 - Product Usage: The HemoSphere oximetry cable is a multi-use device that connects with a compatible Edwards monitor on one end and any a Terminated |
DQK | None listed |
| Jan 16, 2018 | Edwards Lifesciences, LLC Hemosphere System with the following three components: HEM1 Advanced Monitor, HEMSGM10 (Swan-Ganz Module), and HEMOXSC100 (Oximetry Smart Cable).
Product Usage:
The HemoSphere Advanced Monitor (HEM1 Terminated |
DQK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.