FDA 510(k) Application Details - K211407

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K211407
Device Name	Oximeter
Applicant	Belun Technology Company Limited Unit 218, 2/F, Core Building 2, No. 1 Science Park West Avenue, Hong Kong Science Park Sha Tin CN Other 510(k) Applications for this Company
Contact	Leung Lap Wai Lydia 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	05/06/2021
Decision Date	10/21/2021
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