510(k) K053356 ยท DXJ Display, Cathode-Ray Tube, Medical
MODIFICATION TO: CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION
| Applicant | Ge Medical Systems Information Technologies, Milwaukee WI, US |
| Decision | Substantially Equivalent, Apr 19, 2006 |
| Received | Dec 2, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053356
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 12, 2019 | GE Healthcare, LLC CIC Pro Clinical Information Center Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric and neonatal patient data in a centralized location within a hospit Terminated |
DSI | None listed |
| May 4, 2009 | GE Medical Systems Information Tecnology GE Healthcare CIC Pro" Software Versions 5.0.3, 5.0.6 ,5.0.7, 5.0.8 and 4.1.
The CIC Pro" Clinical Information Center Central Station is intended for use under the direct supervision of a licensed h Terminated |
DSI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.