FDA 510(k) Application Details - K000338

Device Classification Name	Standard Polysomnograph With Electroencephalograph   More FDA Info for this Device
510(K) Number	K000338
Device Name	Standard Polysomnograph With Electroencephalograph
Applicant	NIHON KOHDEN AMERICA, INC. 2601 CAMPUS DR. IRVINE, CA 92612-1601 US Other 510(k) Applications for this Company
Contact	BONNIE BISHOP 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	02/03/2000
Decision Date	04/26/2000
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