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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, sleep assessment
510(k) Number K111514
Device Name SBV2, MULTICHARGER MODEL MC10V2
Applicant
SLEEP PERFORMANCE D.B.A. FATIGUE SCIENCE
5405 ALTON PARKWAY
SUITE A530
IRVINE,  CA  92604
Applicant Contact MARC GOODMAN
Correspondent
SLEEP PERFORMANCE D.B.A. FATIGUE SCIENCE
5405 ALTON PARKWAY
SUITE A530
IRVINE,  CA  92604
Correspondent Contact MARC GOODMAN
Regulation Number882.5050
Classification Product Code
LEL  
Date Received06/01/2011
Decision Date 12/16/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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