510(k) K053121 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
TRAM MODULE
| Applicant | GE Healthcare, Needham MA, US |
| Decision | Substantially Equivalent, Apr 5, 2006 |
| Received | Nov 7, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K053121
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 22, 2014 | GE Healthcare, LLC GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage: The TRAM Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric and neonata Terminated |
MHX | None listed |
| Aug 28, 2013 | GE Healthcare, LLC GE Healthcare, TRAM MODULE, High-acuity patient monitoring.
Product Usage: The TRAM Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric and neon Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.