FDA 510(k) Application Details - K071782

Device Classification Name	Standard Polysomnograph With Electroencephalograph   More FDA Info for this Device
510(K) Number	K071782
Device Name	Standard Polysomnograph With Electroencephalograph
Applicant	MICROMED S.P.A. VIA GIOTTO 2 MOGLIANO VENETO (TV) 31021 IT Other 510(k) Applications for this Company
Contact	MONICA CAMILLO Other 510(k) Applications for this Contact
Regulation Number	882.1400   More FDA Info for this Regulation Number
Classification Product Code	OLV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/02/2007
Decision Date	01/10/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	Y
Expedited Review