Cardiac Insight, Inc. - FDA 510(k) Cleared Devices
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Cardiac Insight, Inc. Cardiovascular ✕
3 devices
Cleared
Mar 24, 2017
Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software
Cardiovascular
198d
Cleared
Jul 11, 2015
Stealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation...
Cardiovascular
311d
Cleared
May 29, 2013
STEALTH MONITOR, STEALTH DOCKING CABLE, STEALTH DISPLAY AND STORAGE DEVICE
Cardiovascular
113d