510(k) K970445 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
VITALMAX 4000 CONFIGURED/VITALMAX 4000 MODULAR/VITALMAX 4100/MINIPACK 3100/3000/VITALMAX 800+/MINIPACK 300
| Applicant | Pace Tech Medical Monitors, Inc., Clearwater FL, US |
| Decision | Substantially Equivalent, Jan 30, 1998 |
| Received | Feb 5, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970445
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.