510(k) K151080 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Nihon Kohden CSM 1901 Bedside Monitor
| Applicant | Nihon Kohden, Irvine CA, US |
| Decision | Substantially Equivalent, Nov 5, 2015 |
| Received | Apr 22, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151080
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2017 | Nihon Kohden America Inc Bedside monitor CSM-1901(Life Scope G9) with main unit CU-192RA. The Problem only affects CSM-1901(Life Scope G9) communicating with CNS-6201A (PU-621RA) and CNS-9701A (MU-971RA). Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.