FDA 510(k) Application Details - K971813

Device Classification Name	Standard Polysomnograph With Electroencephalograph   More FDA Info for this Device
510(K) Number	K971813
Device Name	Standard Polysomnograph With Electroencephalograph
Applicant	FERGUSON MEDICAL 3407 BAY AVE. CHICO, CA 95973-8619 US Other 510(k) Applications for this Company
Contact	FRANK FERGUSON 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	05/16/1997
Decision Date	01/16/1998
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