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510(k) Data Aggregation
K Number
K222262Device Name
Sunrise
Manufacturer
Date Cleared
2022-12-22
(147 days)
Product Code
Regulation Number
868.2376Why did this record match?
Product Code :
QRS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Sunrise device is a non-invasive home care aid in the evaluation of obstructive sleep apnea (OSA) in patients 18 years and older with suspicions of sleep breathing disorders.
Device Description
The Sunrise device is a cloud-based software device that analyzes data from a sensor (Sunrise sensor 1 or Sunrise sensor 2) placed on the patient's chin. The device detects respiratory events, identifies sleep stages and position. The device generates sleep parameters, e.g. apnea hypopnea index "Sunrise AHI", and position discrete states. Data collected by the device is integrated in a report for further interpretation by the healthcare provider.
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K Number
DEN210015Device Name
Sunrise Sleep Disorder Diagnostic Aid
Manufacturer
Date Cleared
2022-01-07
(280 days)
Product Code
Regulation Number
868.2376Why did this record match?
Product Code :
QRS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Sunrise SDDA device is a non-invasive home care aid in the evaluation of obstructive sleep apnea (OSA) in patients 18 years and older with suspicions of sleep breathing disorders.
Device Description
The Sunrise SDDA device consists of a Sunrise sensor and a cloud-based software device that analyzes data from the sensor when placed on the patient's mandible. The device also includes a mobile application to record patient's responses to questions about their sleep quality and transfer sensor data to the cloud. By analyzing patient's mandibular movements, the device also detects obstructive respiratory disturbances, identifies sleep states, notifies about the Obstructive Sleep Apnea (OSA) severity in a categorical format (non-OSA, mild-OSA, moderate-OSA, severe-OSA), generates sleep structure information (namely, total sleep time, sleep onset latency, wake after sleep onset, sleep efficiency, arousal index) and head position discrete states. Data collected by the device is integrated in a report for further interpretation and diagnosis by the healthcare provider.
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