Medical Device Manufacturer · US , Milwaukee , WI

Ge Medical Syst. Information Technologies - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2004

Recent clearances: MAC 800 RESTING ECG ANALYSIS SYSTEM, HEART RATE TURBULENCE ANALYSIS TECHNOLOGIES

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Ge Medical Syst. Information Technologies Cardiovascular ✕

2 devices

1-2 of 2

Cleared Feb 19, 2009

MAC 800 RESTING ECG ANALYSIS SYSTEM

Cardiovascular · 22d

Cleared Dec 03, 2004

HEART RATE TURBULENCE ANALYSIS TECHNOLOGIES

Cardiovascular · 116d

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Sep 25, 2026