Medical Device Manufacturer · US , Dallas , TX

Synergen Technology Labs, LLC - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2018

Recent clearances: ScioCardio ECG Analysis Platform, ScioCardio ECG Transmitter

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Synergen Technology Labs, LLC Cardiovascular ✕

2 devices

1-2 of 2

Cleared Jul 09, 2026

ScioCardio ECG Analysis Platform

Cardiovascular · 295d

Cleared May 30, 2018

ScioCardio ECG Transmitter

Cardiovascular · 420d

Data Source

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

Last updated: Aug 06, 2026