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510(k) Data Aggregation
K Number
K112573Device Name
EZSLEEP SLEEP QUALITY RECORDER
Manufacturer
Date Cleared
2012-03-22
(198 days)
Regulation Number
870.2800Why did this record match?
Applicant Name (Manufacturer) :
PLATINUM TEAM CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The EZsleep Sleep Quality Recorder is to be placed on patient's chest for recording of heart rate signals while patient is asleep. The recorded data is for sleep quality analysis. The EZsleep Sleep Quality Recorder is not intended for monitoring purpose.
Device Description
The EZsleep Sleep Quality Recorder is a small battery powered device designed to be simple and easy to use by a patient who suffers from sleep disorder. It is self-contained, with integrated microcontroller and LED displays and all necessary interface electronics for performing recording functions. The device has a storage function in which the recorded signals can be transmitted through a USB port to a computer for data analysis. The proposed device is intended for adults who suffer from sleep disorders such as abnormal pauses in breathing (apnea), or instances of abnormally low breathing during sleep (hypopnea). This device is not intended to substitute for a hospital device for diagnosis of sleep disorders. This device is also not intended for recording and transmission of user's heart rate signal simultaneously. Users with implanted pacemaker are not recommended to use this device.
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