FDA 510(k) Application Details - K162687

Device Classification Name	System, X-Ray, Mobile   More FDA Info for this Device
510(K) Number	K162687
Device Name	System, X-Ray, Mobile
Applicant	MERIDIAN MEDICAL SYSTEMS, LLC 325 HARRIS DRIVE AURORA, OH 442027539 US Other 510(k) Applications for this Company
Contact	Larry Cornell Other 510(k) Applications for this Contact
Regulation Number	892.1720   More FDA Info for this Regulation Number
Classification Product Code	IZL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/27/2016
Decision Date	10/21/2016
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