FDA 510(k) Application Details - K193350

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K193350
Device Name	Oximeter
Applicant	Leadtek Research Inc. 18F, No.166, Jian-Yi Rd., Zhonghe Dist New Taipei City 23511 TW Other 510(k) Applications for this Company
Contact	K. S. 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	12/03/2019
Decision Date	04/27/2020
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