Visicu, Inc.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
7
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0399-2016Class IIThe eCareManager system. Software intended for use in data collection, storage and clinical informaMarch 27, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K211046eCareManager 4.5June 3, 2022
K171322eCareManager 4.1August 3, 2017
K171029eCareCoordinatorJuly 14, 2017
K153156eCareManager 4.0.1September 30, 2016
K141706ECARE COORDINATOR (ECC)September 9, 2014
K012171MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMSJuly 24, 2001
K001972ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORKOctober 27, 2000