Visicu, Inc.
Medical device manufacturer in Baltimore, MD.
7510(k) clearances
0PMA approvals
2recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K211046 | eCareManager 4.5MSX · Traditional | 06/03/2022SE |
| K171322 | eCareManager 4.1MSX · Traditional | 08/03/2017SE |
| K171029 | eCareCoordinatorDRG · Traditional | 07/14/2017SE |
| K153156 | eCareManager 4.0.1MSX · Traditional | 09/30/2016SE |
| K141706 | Ecare Coordinator (Ecc)DRG · Traditional | 09/09/2014SE |
| K012171 | Modification to: Argus System-Continuous Expert Care Network W/Smart AlramsMSX · Special | 07/24/2001SE |
| K001972 | Argus System-Continuous Expert Care NetworkMSX · Traditional | 10/27/2000SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0399-2016 Class II | The eCareManager system. Software intended for use in data collection, storage and…A software defect may cause incorrect medication order change. If the user decides to edit the order prior… | 03/27/2015Terminated |
| Z-1474-2012 | Philips eCareManager System, Model 865325, software versions 3.7, 3.7.1 and 3.8. Product…Three versions of software for the eCareManager failed to display anticoagulants on the medications screen.… | 02/22/2012Terminated |