FDA 510(k) Application Details - DEN230076

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN230076
Device Name	Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP7460 (HEM-7371T1-AZ)); Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP5460 (HEM-7372T1-AZAZ))
Applicant	Omron Healthcare, Inc. 2895 Greenspoint Parkway Suite 100 Hoffman Estates, IL 60169 US Other 510(k) Applications for this Company
Contact	Terri Ingalls Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QXY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/13/2023
Decision Date	10/08/2024
Decision	DENG -
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review