510(k) K161164 ยท MSX System, Network And Communication, Physiological Monitors
CareEvent inclusive of the CareEvent Mobile Application accessory
| Applicant | Philips Medical Systems, Andover MA, US |
| Decision | Substantially Equivalent, Jun 24, 2016 |
| Received | Apr 25, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161164
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 27, 2024 | Philips North America CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), Software Version Number C.03.X Open, Classified |
MSX | None listed |
| Jan 13, 2024 | Philips North America (1) Patient Information Center iX, Model No. 866389
(2) Patient Information Center iX Expand, Model No. 866390
(3) PIC iX Hardware, Model No. 866424 Open, Classified |
MHX | None listed |
| Jan 13, 2024 | Philips North America (1) CareEvent, Model No. 866435
(2) CareEvent Upgrade, Model no. 866436 Open, Classified |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.