510(k) K012171 ยท MSX System, Network And Communication, Physiological Monitors
MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMS
| Applicant | Visicu, Inc., Baltimore MD, US |
| Decision | Substantially Equivalent, Jul 24, 2001 |
| Received | Jul 12, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K012171
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 10, 2015 | Visicu, Inc. The eCareManager system. Software intended for use in data collection, storage and clinical information management with independent bedside devices, and ancillary systems that are connected either di Terminated |
MSX | None listed |
| Apr 27, 2012 | Visicu, Inc. Philips eCareManager System, Model 865325, software versions 3.7, 3.7.1 and 3.8.
Product Usage: The Philips eCareManager System software is intended for use in data collection, storage, and clinica Terminated |
MSX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.