FDA 510(k) Application Details - K190869

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K190869
Device Name	Oximeter
Applicant	Shenzhen Aeon Technology Co., Ltd. RM6H02, Block 27-29, Tianxia IC Industrial Park, Majialong No.133 of Yiyuan road, Nantou Street, Nanshan District Shenzhen 518052 CN Other 510(k) Applications for this Company
Contact	Xie Hua Other 510(k) Applications for this Contact
Regulation Number	870.2700   More FDA Info for this Regulation Number
Classification Product Code	DQA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/03/2019
Decision Date	09/13/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review