Onera Sleep Test System (Onera STS)— 510(k) K210593

Substantially Equivalent

Onera B.V.

FDA 510(k) clearance K210593 for Onera Sleep Test System (Onera STS), Substantially Equivalent on 2022-04-06. Applicant: Onera B.V.. Device class: 2.

Clearance details

Applicant: Onera B.V.
Product code: Code MNR
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 2021-03-01
Decision date: 2022-04-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eindhoven, NL

Download summary PDF View on FDA.gov ↗

Recent devices under product code MNR

More clearances from Onera B.V.

K253668 — Onera SleepMap (SLEEPMAP)2026-03-08
K243220 — Onera STS 2 (ONERA STS 2)2025-07-03
K223573 — Onera Sleep Test System (Onera STS)2023-08-18

Data sourced from openFDA. This site is unofficial and independent of the FDA.