510(k) K112803 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
PATIENT MONITOR
| Applicant | Guangdong Biolight Meditech Co., Ltd., Shanghai, CN |
| Decision | Substantially Equivalent, Oct 24, 2011 |
| Received | Sep 27, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K112803
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.