510(k) K101521 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
ST/AR ST AND ARRHYTHMIA SOFTWARE MODEL: RELEASE K.O
| Applicant | Philips Medical Systems, Andover MA, US |
| Decision | Substantially Equivalent, Jul 29, 2010 |
| Received | Jun 2, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K101521
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.