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FDA 510(k)

Onera Sleep Test System (Onera STS)

K-Number: K210593 · 2022-04-06

ApplicantOnera B.V.
Decision Date2022-04-06
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Onera Sleep Test System (Onera STS) is a medical device manufactured by Onera B.V.. It received FDA 510(k) clearance on 2022-04-06 under approval number K210593. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Onera Sleep Test System (Onera STS)?

Onera Sleep Test System (Onera STS) is a medical device that received FDA 510(k) clearance on 2022-04-06. It is manufactured by Onera B.V.. The 510(k) number is K210593.

When was Onera Sleep Test System (Onera STS) approved by the FDA?

Onera Sleep Test System (Onera STS) received FDA 510(k) clearance on 2022-04-06, under approval number K210593.

What company makes Onera Sleep Test System (Onera STS)?

Onera Sleep Test System (Onera STS) is manufactured by Onera B.V..

What is the FDA product code for Onera Sleep Test System (Onera STS)?

The FDA product code for Onera Sleep Test System (Onera STS) is MNR.

Related Clinical Trials

NCT05016219 Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients RECRUITING NCT07608614 Sleep and Performance RECRUITING NCT04121923 Validation of a Novel Device for Screening Patients With Symptoms of Obstructive Sleep Apnea COMPLETED NCT02703207 Neurocognitive and Health Impact of Sleep Apnea in Elderly Veterans With Comorbid COPD RECRUITING NCT00743561 Assessment of Ambulatory Polygraphy in the Detection of Sleep Apnea in Multiple System Atrophy (SAMSA) COMPLETED NCT07574918 Measuring Nasal Airway Changes After VivAer Treatment Using AI Analysis NOT_YET_RECRUITING

Other Devices by Onera B.V.

K223573Onera Sleep Test System (Onera STS) K243220Onera STS 2 (ONERA STS 2) K253668Onera SleepMap (SLEEPMAP)

Related Devices (Code: MNR)

K153070Watch-PAT200UItamar Medical , Ltd. K151874BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/NasalSalter Labs K151433AUDICOR CA300/CC100 Analyzer with SDBInovise Medical, Inc. K163696SleepImage SystemMycardio, LLC Dba Sleepimage. K163665MATRx plusZephyr Sleep Technologies K160499Apnea Risk Evaluation System (ARES), Model 620Watermark Medical

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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