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510(k) Data Aggregation
K Number
K965079Device Name
SOMNITOR 32K SLEEP ACTIVITY MONITOR
Manufacturer
Date Cleared
1997-07-10
(203 days)
Product Code
Regulation Number
882.5050Why did this record match?
Applicant Name (Manufacturer) :
NEURIM PHARMACEUTICALS, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Somnitor 32K Activity Monitor is intended to monitor physical activity with an ambulatory monitoring and data logging device and after downloading the data to a personal computer, determine the periods when the patient was awake or sleeping using a validated algorithm.
Device Description
The Somnitor 32K Activity Monitor is a wrist worn device consisting of an activity (movement) detector and a data logger with internal data storage. The device is used with a personal computer running software which can download data from the data logger and analyze it according to a validated algorithm to determine periods of sleep and wakefulness. Four algorithms for assessing sleep activity data may be used for analysis, including the Bounded Trigger algorithm, the Cole algorithm, the Sadeh algorithm, and a new Neurim algorithm.
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