FDA 510(k) Application Details - K180685

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K180685
Device Name	Oximeter
Applicant	Xiamen Acurio Instruments Co., Ltd 3rd-4th Floors, BI Park, No.2028 Wengjiao West Road, Haicang District Xiamen 361026 CN Other 510(k) Applications for this Company
Contact	Angel Liu 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	03/15/2018
Decision Date	11/29/2018
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