FDA 510(k) Application Details - K981114

Device Classification Name	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase   More FDA Info for this Device
510(K) Number	K981114
Device Name	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Applicant	ORIDION MEDICAL LTD. 7 HAMARPE ST. P.O. BOX 45025 JERUSALEM 91450 IL Other 510(k) Applications for this Company
Contact	SANFORD BROWN 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	03/27/1998
Decision Date	06/25/1998
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