FDA 510(k) Application Details - K111514

Device Classification Name	Device, Sleep Assessment   More FDA Info for this Device
510(K) Number	K111514
Device Name	Device, Sleep Assessment
Applicant	SLEEP PERFORMANCE D.B.A. FATIGUE SCIENCE 5405 ALTON PARKWAY SUITE A530 IRVINE, CA 92604 US Other 510(k) Applications for this Company
Contact	MARC GOODMAN Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LEL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/01/2011
Decision Date	12/16/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review