510(k) K992637 ยท DSI Detector And Alarm, Arrhythmia
MUSE CARDIOVASCULAR INFORMATION SYSTEM
| Applicant | General Electric Medical Systems Information Techn, Milwaukee WI, US |
| Decision | Substantially Equivalent, Nov 3, 1999 |
| Received | Aug 6, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992637
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 10, 2025 | GE Medical Systems Information Technologies Inc MUSE 5 Systems, Model Numbers 2021274-001, 2023032-005, 2027478-001, Large capacity client-server-based computer system that accesses stores and manages cardiovascular information. Open, Classified |
DSI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.