Medical Device Manufacturer · NL , Eindhoven

Onera B.V. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2022

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Onera B.V. Neurology ✕

4 devices

1-4 of 4

Cleared CT Mar 08, 2026

Onera SleepMap (SLEEPMAP)

Neurology · 107d

Cleared Jul 03, 2025

Onera STS 2 (ONERA STS 2)

Neurology · 269d

Cleared Aug 18, 2023

Onera Sleep Test System (Onera STS)

Neurology · 261d

Cleared Apr 06, 2022

Onera Sleep Test System (Onera STS)

Neurology · 401d

Data Source

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

Last updated: Apr 27, 2026