Cleared Traditional

Onera Sleep Test System (Onera STS)

K223573 · Onera B.V. · Neurology
Aug 2023
Decision
261d
Days
Class 2
Risk

About This 510(k) Submission

K223573 is an FDA 510(k) clearance for the Onera Sleep Test System (Onera STS), a Ventilatory Effort Recorder (Class II — Special Controls, product code MNR), submitted by Onera B.V. (Eindhoven, NL). The FDA issued a Cleared decision on August 18, 2023, 261 days after receiving the submission on November 30, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 868.2375.

Submission Details

510(k) Number K223573 FDA.gov
FDA Decision Cleared SESE
Date Received November 30, 2022
Decision Date August 18, 2023
Days to Decision 261 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code MNR — Ventilatory Effort Recorder
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.2375