FDA 510(k) Application Details - K240305

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K240305
Device Name	Oximeter
Applicant	Sibel Health Inc. 2017 N Mendell St. Suite 2SE Chicago, IL 60614 US Other 510(k) Applications for this Company
Contact	Sarah Coughlin 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	02/02/2024
Decision Date	05/28/2024
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