510(k) K100046 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
M SEIRES PATIENT MONITOR MODEL M66, M69, M8000, M9000, M7000
| Applicant | Guangdong Biolight Meditech Co., Ltd., Shanghai, CN |
| Decision | Substantially Equivalent, Apr 8, 2010 |
| Received | Jan 8, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100046
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.