510(k) K080495 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
SURESIGNS VM SERIES PATIENT MONITOR, MODELS VM4, VM6, VM8, VM3 AND VS3
| Applicant | Philips Medical Systems, Andover MA, US |
| Decision | Substantially Equivalent, Mar 24, 2008 |
| Received | Feb 22, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K080495
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 13, 2018 | Philips Electronics North America Corporation Philips SureSigns VM 3/4/6/8 Patient Monitors, 863063
863064
863065
863066
863068
863077
863085
863086
863317
863287
863288
863289
The SureSigns VM4, VM6, and VM8 patient monitors are for use by hea Open, Classified |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.