FDA 510(k) Application Details - K232495

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K232495
Device Name	Oximeter
Applicant	Sempulse Corporation 3055 Hunter Road, Suite 175A San Marcos, TX 78666 US Other 510(k) Applications for this Company
Contact	Matt Barrera 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	08/17/2023
Decision Date	05/16/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review