FDA 510(k) Application Details - K132764

Device Classification Name	Device, Sleep Assessment   More FDA Info for this Device
510(K) Number	K132764
Device Name	Device, Sleep Assessment
Applicant	CAMNTECH, LTD UPPER PENDRILL COURT PAPWORTH EVERARD, CAMBRIDGESHIRE CB233UY GB Other 510(k) Applications for this Company
Contact	HOWARD SMITH 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	09/04/2013
Decision Date	01/21/2014
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