510(k) K042642 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
AWARE TRANSPORT MONITOR SYSTEM (INCLUDES AWARE POD AND AWARE TRANSPORT MONITOR)
| Applicant | Ge Medical Systems Information Technologies, Milwaukee WI, US |
| Decision | Substantially Equivalent, Nov 3, 2004 |
| Received | Sep 27, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042642
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 16, 2012 | GE Healthcare, LLC GE Healthcare, Invasive Blood Pressure Care Cables.
Product ID Number: 2016995-001, 2016995-002, 2016995-003, 2016995-004. Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.