510(k) K171580 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Monitor B125, Monitor B105
| Applicant | Ge Medical Systems (China) Co., Ltd., Wuxi, CN |
| Decision | Substantially Equivalent, Nov 1, 2017 |
| Received | May 31, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171580
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2018 | GE Healthcare, LLC B105/125 Patient Monitor.
The device is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, a Open, Classified |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.