FDA 510(k) Application Details - K163135

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K163135
Device Name	Oximeter
Applicant	SHENZHEN FITFAITH TECHNOLOGY CO.,LTD AREA B, FLOOR 9, BUILDING D1, TANGWEI INDUSTRIAL PARK, DONGLONG RD Guangming New District, Shenzhen 518000 CN Other 510(k) Applications for this Company
Contact	Yuan Junfeng 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	11/08/2016
Decision Date	09/19/2017
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