FDA 510(k) Application Details - K180837

Device Classification Name	Generator, Oxygen, Portable   More FDA Info for this Device
510(K) Number	K180837
Device Name	Generator, Oxygen, Portable
Applicant	Contec Medical System Co., Ltd. No. 112 Qinhuang West Street, Economic & Technical Development Zone Qinhuangdao 066004 CN Other 510(k) Applications for this Company
Contact	Xueyong Li Other 510(k) Applications for this Contact
Regulation Number	868.5440   More FDA Info for this Regulation Number
Classification Product Code	CAW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/30/2018
Decision Date	01/10/2019
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