FDA 510(k) Application Details - K040011

Device Classification Name	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase   More FDA Info for this Device
510(K) Number	K040011
Device Name	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Applicant	ORIDION LTD. 21 HIGHLAND CIRCLE NEEDHAM, MA 02494-3038 US Other 510(k) Applications for this Company
Contact	DOMINIC CORSALE 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	01/05/2004
Decision Date	05/13/2004
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