510(k) K012016 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
INFINITY SC 8000 WITH ADVANCED COMMUNICATION OPTION II
| Applicant | Siemens Medical Solutions USA, Inc., Danvers MA, US |
| Decision | Substantially Equivalent, Jul 20, 2001 |
| Received | Jun 28, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K012016
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.