FDA 510(k) Application Details - K201360

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K201360
Device Name	Oximeter
Applicant	Xinkang Medical Instrument Co. Ltd. 2 Floor, Puhua S&T Park, Tongsheng Community Dalang Street, Longhua District Shenzhen 518109 CN Other 510(k) Applications for this Company
Contact	Xu Changsheng 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	05/21/2020
Decision Date	08/19/2020
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