FDA 510(k) Application Details - K201384

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K201384
Device Name	Oximeter
Applicant	Shenzhen Raysintone Technology CO., Ltd Zone C, 4th Floor, F Building, Xinwei Second Industrial Zone Guangming District Shenzhen 518106 CN Other 510(k) Applications for this Company
Contact	Xingbao Yang 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	05/26/2020
Decision Date	12/07/2020
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