FDA 510(k) Application Details - K192541

Device Classification Name	System, X-Ray, Stationary   More FDA Info for this Device
510(K) Number	K192541
Device Name	System, X-Ray, Stationary
Applicant	Allengers Medical Systems Limited 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	892.1680   More FDA Info for this Regulation Number
Classification Product Code	KPR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/16/2019
Decision Date	10/16/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review