FDA 510(k) Application Details - K240840

Device Classification Name	Generator, Oxygen, Portable   More FDA Info for this Device
510(K) Number	K240840
Device Name	Generator, Oxygen, Portable
Applicant	Foshan Care Medical Technology Co., Ltd. #2 Haitang Rd, National Ecological Industrial Park Danzao Town, Nanhai District Foshan 528000 CN Other 510(k) Applications for this Company
Contact	Leona Zhou 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	03/27/2024
Decision Date	12/06/2024
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