FDA 510(k) Application Details - K210305

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K210305
Device Name	Oximeter
Applicant	Dongguan Lingxin Technologies Co., LTD Room 301, No. 3 Liantang Road, Aoshitang, Dongcheng Street Dongguan 523129 CN Other 510(k) Applications for this Company
Contact	Cony Tang 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	02/03/2021
Decision Date	12/22/2021
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