FDA 510(k) Application Details - K202776

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K202776
Device Name	Oximeter
Applicant	Shenzhen LEPU Intelligent Medical Equipment Co., Ltd. North side of floor 3, BLD 9 BaiWangxin High-Tech Industrial Park, Songbai Roa Shenzhen 518055 CN Other 510(k) Applications for this Company
Contact	Aaron Lin 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	09/21/2020
Decision Date	03/01/2021
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