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Found 3 results
510(k) Data Aggregation
K Number
K243220Device Name
Onera STS 2 (ONERA STS 2)
Manufacturer
Onera B.V.
Date Cleared
2025-07-03
(269 days)
Product Code
MNR
Regulation Number
868.2375Why did this record match?
Applicant Name (Manufacturer) :
Onera B.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K223573Device Name
Onera Sleep Test System (Onera STS)
Manufacturer
Onera B.V.
Date Cleared
2023-08-18
(261 days)
Product Code
MNR
Regulation Number
868.2375Why did this record match?
Applicant Name (Manufacturer) :
Onera B.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Onera STS measures and records multiple physiological parameters from a patient during a sleep study which are used by clinicians to make a decision on the diagnosis of sleep disorders.
Onera STS is intended to be used on a patient, who has been prescribed a sleep study by a healthcare professional. The device is designed to be used under the direction of a physician or trained technician but applied by a layperson. The recorded data will be made available to a healthcare professional to assist in the diagnosis of sleep disorders.
The device is intended to be used for adults.
Device Description
Onera STS is a wearable system for measuring (physiological) signals during a sleep study. The device can be used in home (Home Healthcare Environment) as well as Professional Healthcare Facilities, to perform the sleep study.
Onera STS consists of four sensors applied on the forehead, upper chest area, abdominal and lower leg area.
The sensors measure EEG, EOG, EMG, ECG, bioimpedance based respiratory effort, bioimpedance based respiratory flow, cannula based respiratory flow, oxygen saturation, activity, position, and sound pressure level.
The study preparation and data retrieval are done in a professional/clinical environment by the trained operator. The device is provided to the user by the trained operator.
The device is not a life supporting physiological monitor.
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K Number
K210593Device Name
Onera Sleep Test System (Onera STS)
Manufacturer
Onera B.V.
Date Cleared
2022-04-06
(401 days)
Product Code
MNR, OLV
Regulation Number
868.2375Why did this record match?
Applicant Name (Manufacturer) :
Onera B.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Onera STS measures and records multiple physiological parameters from a sleep study which are used by clinicians to make a decision on the diagnosis of sleep disorders.
Onera STS is intended to be used on a patient, who has been prescribed a sleep study by a healthcare professional. The device is designed to be used under the direction of a physician or trained technician but applied by a layperson.
The recorded data will be made available to a healthcare professional to assist in the diagnosis of sleep disorders.
The device is intended to be used for adults.
Device Description
Onera STS is a wearable system for measuring (physiological) signals during a sleep study. The device can be used in home (Home Healthcare Environment) as well as Professional Healthcare Facilities, to perform the sleep study.
Onera STS consists of four sensors applied on the forehead, upper chest area, abdominal and lower leg area.
The sensors measure EEG, EOG, EMG, ECG, bioimpedance based respiratory effort, bioimpedance based respiratory flow, cannula based respiratory flow, oxygen saturation, activity, position, and sound pressure level.
The study preparation and data retrieval are done in a professional/clinical environment by a dedicated trained operator.
The device is not a life supporting physiological monitor
Ask a Question
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