FDA 510(k) Application Details - K221361

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K221361
Device Name	Oximeter
Applicant	BodiMetrics, LLC 1601 N. Sepulveda Blvd, Suite 839 Manhattan Beach, CA 90266 US Other 510(k) Applications for this Company
Contact	Mark Goettling 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	05/11/2022
Decision Date	08/29/2023
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