FDA 510(k) Application Details - K210032

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K210032
Device Name	Oximeter
Applicant	Leadtek Research Inc. 18F, No. 166, Jian-Yi Rd., Chung Ho Dist. New Taipei City 23511 TW Other 510(k) Applications for this Company
Contact	Kun-Shan Lu 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	01/05/2021
Decision Date	09/01/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review