FDA 510(k) Application Details - K040932

Device Classification Name	Device, Sleep Assessment   More FDA Info for this Device
510(K) Number	K040932
Device Name	Device, Sleep Assessment
Applicant	CADWELL LABORATORIES, INC. 909 NORTH KELLOGG ST. KENNEWICK, WA 99336 US Other 510(k) Applications for this Company
Contact	CHRIS BOLKAN 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	04/09/2004
Decision Date	07/01/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review