Medical Device Manufacturer · US , Plano , TX

Elekon Industries U.S.A., Inc. - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2004

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Elekon Industries U.S.A., Inc. Anesthesiology ✕

6 devices

1-6 of 6

Cleared Dec 29, 2004

DISPOSABLE NON-ADHESIVE SPO2 SENSORS

Anesthesiology · 90d

Cleared Dec 06, 2004

FLEXI-STAT SP02 EAR SENSOR

Anesthesiology · 68d

Cleared Nov 26, 2004

REUSABLE FINGER CLIP SPO2 SENSORS

Anesthesiology · 57d

Cleared Sep 14, 2004

FLEXI-STAT DISPOSABLE ADHESIVE SPO2 SENSORS

Anesthesiology · 99d

Cleared Sep 02, 2004

FLEXI-STAT REUSABLE FINGER CLIP SPO2 SENSORS...

Anesthesiology · 77d

Cleared Jul 29, 2004

FLEXI-STAT DISPOSABLE NON-ADHESIVE SPO2 SENSORS, (NELLCOR-COMPATIBLE),...

Anesthesiology · 42d

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: Apr 27, 2026