510(k) K081983 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE 1.00
| Applicant | Philips Medical Systems, Andover MA, US |
| Decision | Substantially Equivalent, Aug 22, 2008 |
| Received | Jul 11, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K081983
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 10, 2012 | Philips Healthcare Inc. Philips IntelliVue Information Center/Client and Philips IntelliVue Information Center iX
The intended use of the Information Center Software is to display physiologic waves, parameters, and trends, Terminated |
MHX | None listed |
| May 19, 2011 | Philips Healthcare Inc. Philips Audio-Video Engineering PAS-210 Remote Active Speakers Kit used with the IntelliVue Information Center
The intended use of the Information Center Software is to display physiologic waves, para Terminated |
MHX | None listed |
| Jan 27, 2011 | Philips Healthcare Inc. Physiological Monitoring, Patient Monitor
M31250 Information Center Local Database
Releases A, B, E.01, G, H, J, K, L, & M of Philips IntelliVue Information Center Software used in conjunction with PA Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.