FDA 510(k) Application Details - K190792

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K190792
Device Name	Oximeter
Applicant	BioBeat Technologies Ltd. 26 HaÆmagshimim Street Petah Tikvah 4934835 IL Other 510(k) Applications for this Company
Contact	Johanan May 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	03/27/2019
Decision Date	08/22/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review