510(k) K110622 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
INTELLIVUE PATIENT MONITOR
| Applicant | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, Boeblingen, Baden-Wuerttemberg, DE |
| Decision | Substantially Equivalent, Mar 31, 2011 |
| Received | Mar 3, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K110622
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 16, 2014 | Philips Medical Systems, Inc. Lithium Ion Battery M4605A and M4607A for use with IntelliVue Patient Monitors. The monitor is used for monitoring and recording of, and to generate alarms for, multiple physiological parameters. Terminated |
MHX | None listed |
| Mar 1, 2012 | Philips Healthcare Inc. Philips IntelliVue Patient Monitors:
The monitor is intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neona Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.