FDA 510(k) Application Details - K223740

Device Classification Name	Generator, Oxygen, Portable   More FDA Info for this Device
510(K) Number	K223740
Device Name	Generator, Oxygen, Portable
Applicant	Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd. NO.8, Shengchang West Road, Danyang Economy Development Zone Danyang, Jiangsu, China Jiangsu 212300 CN Other 510(k) Applications for this Company
Contact	Heidi Zhang 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	12/14/2022
Decision Date	10/05/2023
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