FDA 510(k) Application Details - K203623

Device Classification Name	More FDA Info for this Device
510(K) Number	K203623
Device Name	StentBoost Mobile
Applicant	Philips India Limited Plot No. B-79, MIDC, Phase-II, Chakan, Taluka- Khed, Village - Savardari Pune 410501 IN Other 510(k) Applications for this Company
Contact	Shruti Sancheti Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/11/2020
Decision Date	04/05/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review