FDA 510(k) Application Details - K210371

Device Classification Name	Generator, Oxygen, Portable   More FDA Info for this Device
510(K) Number	K210371
Device Name	Generator, Oxygen, Portable
Applicant	Qingdao Kingon Medical Science and Technology Co., Ltd. Room 301-302, No.15 HanchengRoad Qingdao Free Trade Zone 266555 CN Other 510(k) Applications for this Company
Contact	Zhang Benrong 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	02/08/2021
Decision Date	06/03/2022
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