FDA 510(k) Application Details - K181467

Device Classification Name	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase   More FDA Info for this Device
510(K) Number	K181467
Device Name	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Applicant	Oridion Medical 1987 Ltd. 7 Hamarpe Street P.O. Box 45025 Jerusalem 9777407 IL Other 510(k) Applications for this Company
Contact	Dalia Givony 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	06/04/2018
Decision Date	02/08/2019
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