510(k) K013311 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
MODIFICATION TO: POCKETVIEW ECG SOFTWARE
| Applicant | Micromedical Industries, Ltd., Labrador, Queensland, AU |
| Decision | Substantially Equivalent, Jan 3, 2002 |
| Received | Oct 4, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K013311
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.