FDA 510(k) Application Details - K243062

Device Classification Name	More FDA Info for this Device
510(K) Number	K243062
Device Name	BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); BD Intelliport Mount (516233); BD Intelliport Charger (516231)
Applicant	Becton Dickinson 1 Becton Drive Franklin Lakes, NJ 07417 US Other 510(k) Applications for this Company
Contact	Tim Wade Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PHC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/27/2024
Decision Date	06/20/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review