Medical Device Manufacturer · US , Ronkonkoma , NY

Lutech Industries, Inc. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2014

Recent clearances: LT-300 SD Digital Video Colposcope, LT-300 HD, Datalys Multi-Parameter Patient Monitor

View 4 510(k) Devices ↓

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Lutech Industries, Inc. Cardiovascular ✕

1 devices

1-1 of 1

Cleared May 15, 2015

Datalys Multi-Parameter Patient Monitor

Cardiovascular · 58d

Data Source

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

Last updated: Sep 14, 2026