FDA 510(k) Application Details - K122075

Device Classification Name	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase   More FDA Info for this Device
510(K) Number	K122075
Device Name	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Applicant	INTERSURGICAL, INC. 417 ELECTRONICS PKWY. LIVERPOOL, NY 13088 US Other 510(k) Applications for this Company
Contact	MICHAEL ZALEEWSKI 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	07/16/2012
Decision Date	12/20/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review