FDA 510(k) Application Details - K200218

Device Classification Name	More FDA Info for this Device
510(K) Number	K200218
Device Name	Digiscan FDX
Applicant	Allengers Medical Systems Limited FDA Hall, Unit II Bhankharpur, 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	01/28/2020
Decision Date	07/13/2020
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