510(k) K980619 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
SABRATEK PATIENT HOME MANAGEMENT SYSTEM
| Applicant | Sabratek Corp., Niles IL, US |
| Decision | Substantially Equivalent, Aug 20, 1998 |
| Received | Feb 18, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980619
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.