FDA 510(k) Application Details - K242718

Device Classification Name	Generator, Oxygen, Portable   More FDA Info for this Device
510(K) Number	K242718
Device Name	Generator, Oxygen, Portable
Applicant	Qingdao Kingon Medical Science and Technology Co., Ltd Room 301-302(B), No.15 Hancheng Road,Qingdao Free Trade Zone 24th Building, NO. 252 Yanhe Road, Huangdao Qingdao 266510 CN Other 510(k) Applications for this Company
Contact	Benrong 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	09/10/2024
Decision Date	02/28/2025
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