FDA 510(k) Application Details - K062115

Device Classification Name	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase   More FDA Info for this Device
510(K) Number	K062115
Device Name	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Applicant	NIHON KOHDEN AMERICA, INC. 90 ICON ST. FOOTHILL RANCH, CA 92610-1601 US Other 510(k) Applications for this Company
Contact	SERRAH NAMINI Other 510(k) Applications for this Contact
Regulation Number	868.1400   More FDA Info for this Regulation Number
Classification Product Code	CCK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/24/2006
Decision Date	12/27/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review