Onera SleepMap (SLEEPMAP)— 510(k) K253668

Substantially Equivalent

Onera B.V.

FDA 510(k) clearance K253668 for Onera SleepMap (SLEEPMAP), Substantially Equivalent on 2026-03-08. Applicant: Onera B.V.. Device class: 2.

Clearance details

Applicant: Onera B.V.
Product code: Code OLZ
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2025-11-21
Decision date: 2026-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eindhoven, NL

Download summary PDF View on FDA.gov ↗

Recent devices under product code OLZ

More clearances from Onera B.V.

K243220 — Onera STS 2 (ONERA STS 2)2025-07-03
K223573 — Onera Sleep Test System (Onera STS)2023-08-18
K210593 — Onera Sleep Test System (Onera STS)2022-04-06

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