510(k) K123900 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8
| Applicant | Philips Medical Systems, Andover MA, US |
| Decision | Substantially Equivalent, Apr 18, 2013 |
| Received | Dec 18, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K123900
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 23, 2021 | Philips North America, LLC Philips SureSigns VM4, VM6 and VM8 - Product Usage: patient monitors-for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare envir Terminated |
MHX | None listed |
| 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.