FDA 510(k) Application Details - K191574

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K191574
Device Name	Oximeter
Applicant	S.L.P. Ltd. 62 Anilewicz Street Tel-Aviv 67060 IL Other 510(k) Applications for this Company
Contact	Avi Yosef 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	06/14/2019
Decision Date	04/09/2020
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