510(k) K101692 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
PATIENT MONITOR
| Applicant | Contec Medical System Co., Ltd., Zhong Shan, Shanghai, CN |
| Decision | Substantially Equivalent, Jun 28, 2011 |
| Received | Jun 16, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101692
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 14, 2025 | Contec Medical Systems Co., Ltd. CMS8000 Patient Monitor Open, Classified |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.