Visicu, Inc. - FDA 510(k) Cleared Devices
Recent clearances: eCareManager 4.5, eCareManager 4.1, eCareCoordinator
7
Total
7
Cleared
0
Denied
FDA 510(k) Regulatory Record - Visicu, Inc. Cardiovascular ✕
7 devices
Cleared
Jun 03, 2022
eCareManager 4.5
Cardiovascular
421d
Cleared
Aug 03, 2017
eCareManager 4.1
Cardiovascular
90d
Cleared
Jul 14, 2017
eCareCoordinator
Cardiovascular
99d
Cleared
Sep 30, 2016
eCareManager 4.0.1
Cardiovascular
333d
Cleared
Sep 09, 2014
ECARE COORDINATOR (ECC)
Cardiovascular
77d
Cleared
Jul 24, 2001
MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMS
Cardiovascular
12d
Cleared
Oct 27, 2000
ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK
Cardiovascular
121d