Global Instrumentation, LLC - FDA 510(k) Cleared Devices
Recent clearances: M12 Telemetry System, M5 Recorder
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Global Instrumentation, LLC Cardiovascular ✕
5 devices
Cleared
May 29, 2026
M12 Telemetry System
Cardiovascular
266d
Cleared
Dec 29, 2020
M5 Recorder
Cardiovascular
124d
Cleared
May 24, 2017
Matrix Data Management System
Cardiovascular
264d
Cleared
Apr 22, 2016
Matrix Mini ECG Monitor
Cardiovascular
214d
Cleared
Sep 26, 2005
MATRIX HOLTER SYSTEM, MODEL M12
Cardiovascular
91d