510(k) K100040 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
BIOHARNESS
| Applicant | Zephyr Technology Corporation, Annapolis MD, US |
| Decision | Substantially Equivalent, Dec 3, 2010 |
| Received | Jan 7, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100040
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.