FDA 510(k) Application Details - K220311

Device Classification Name	More FDA Info for this Device
510(K) Number	K220311
Device Name	Cardiovascular Angiography System
Applicant	Allengers Medical Systems Limited FDA Hall Unit-2, Bhankarpur, Mubarakpur Road Derabassi, Distt. Mohali 140507 IN Other 510(k) Applications for this Company
Contact	Sanjeev K. Marjara 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	02/02/2022
Decision Date	05/03/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review