FDA 510(k) Application Details - K241090

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K241090
Device Name	Oximeter
Applicant	Movano Inc. dba Movano Health 6800 Koll Center Parkway, Suite 160 Pleasanton, CA 94566 US Other 510(k) Applications for this Company
Contact	Kim Tompkins 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	04/22/2024
Decision Date	11/29/2024
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