FDA 510(k) Application Details - K213825

Device Classification Name	Generator, Oxygen, Portable   More FDA Info for this Device
510(K) Number	K213825
Device Name	Generator, Oxygen, Portable
Applicant	Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. No. 1 Baisheng Road, Development Zone, Danyang 212300 CN Other 510(k) Applications for this Company
Contact	Wei Yan 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	12/08/2021
Decision Date	04/28/2023
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