FDA 510(k) Application Details - K182880

Device Classification Name	System, X-Ray, Stationary   More FDA Info for this Device
510(K) Number	K182880
Device Name	System, X-Ray, Stationary
Applicant	Halifax Biomedical, Inc. 11493 Route 19 Mabou B0E1X0 CA Other 510(k) Applications for this Company
Contact	Crystal Jones 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	10/15/2018
Decision Date	10/31/2018
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