510(k) K113045 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
BIOHARNESS
| Applicant | Zephyr Technology Corporation, Stamford CT, US |
| Decision | Substantially Equivalent, Aug 14, 2012 |
| Received | Oct 13, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113045
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.