FDA 510(k) Application Details - K131506

Device Classification Name	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase   More FDA Info for this Device
510(K) Number	K131506
Device Name	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Applicant	ABEON MEDICAL CORPORATION 8000 KATHERINE BOULEVARD BRECKSVILLE, OH 44141 US Other 510(k) Applications for this Company
Contact	ALLISON SLAGA 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	05/24/2013
Decision Date	03/06/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review