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510(k) Data Aggregation
K Number
K111514Device Name
SBV2, MULTICHARGER MODEL MC10V2
Manufacturer
SLEEP PERFORMANCE D.B.A. FATIGUE SCIENCE
Date Cleared
2011-12-16
(198 days)
Product Code
LEL
Regulation Number
882.5050Why did this record match?
Applicant Name (Manufacturer) :
SLEEP PERFORMANCE D.B.A. FATIGUE SCIENCE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SBV2 System is an activity monitor designed and intended for documenting physical movements associated with applications in physiological monitoring. The device's intended use is to analyze limb activity associated with movement during sleep and to extract information about certain sleep parameters from these movements. SBV2 can also be used to assess activity in any instance where quantifiable analysis of physical motion is desirable. The use of SBV2 is indicated for adults 22 years of age and over.
Device Description
The SBV2 System is a device that monitors activity. It relies on the measurement and analysis of wrist movements to detect and characterize sleep/wake periods. The device allows some aspects of sleep derived from the analysis of activity to be reported. The SBV2 System is graphically depicted in Figure 1.
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