510(k) K152864 ยท DQK Computer, Diagnostic, Programmable
Merge Hemo
| Applicant | Merge Healthcare Incorporated, Hartland WI, US |
| Decision | Substantially Equivalent, Apr 7, 2016 |
| Received | Sep 30, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152864
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 23, 2021 | Merge Healthcare, Inc. Merge Hemo, Software packages 10.2, 10.3, and 10.4 Terminated |
DQK | None listed |
| Apr 6, 2017 | Merge Healthcare, Inc. Fellows "Mighty 8" Power strip (Part Number 04175-0008) and TrippLite Power strip (PS-415-HGULTRA - Part Number 13-00106-00) are two components sold as part of the Merge Hemo System. Terminated |
DQK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.