Cleared Traditional

Onera Sleep Test System (Onera STS)

K210593 · Onera B.V. · Neurology
Apr 2022
Decision
401d
Days
Class 2
Risk

About This 510(k) Submission

K210593 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 April 6, 2022, 401 days after receiving the submission on March 1, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 868.2375.

Submission Details

510(k) Number K210593 FDA.gov
FDA Decision Cleared SESE
Date Received March 01, 2021
Decision Date April 06, 2022
Days to Decision 401 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