510(k) K101067 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8 MODEL: 863063, 863064, 863065, 863066, 863068
| Applicant | Philips Medical Systems, Andover MA, US |
| Decision | Substantially Equivalent, May 7, 2010 |
| Received | Apr 16, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K101067
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 17, 2011 | Philips Healthcare Inc. Philips SureSigns VM Series Patient Monitors:
VM4, VM6, VM 8:
Model Part Numbers
VM4 863063, 453564024371, 453564021961, 453564024401, 453564021971
VM6 863064, 863065, 453564024421, 453564022001, 453 Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.