510(k) K152993 ยท DQK Computer, Diagnostic, Programmable
MUSE Cardiology Information System
| Applicant | Ge Medical Systems Information Technologies, Inc., Wauwatosa WI, US |
| Decision | Substantially Equivalent, Jan 12, 2016 |
| Received | Oct 13, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K152993
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 16, 2022 | GE Healthcare, LLC MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-008 Terminated |
DQK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.