FDA 510(k) Application Details - K182317

Device Classification Name	System, X-Ray, Mobile   More FDA Info for this Device
510(K) Number	K182317
Device Name	System, X-Ray, Mobile
Applicant	OEHM UND REHBEIN GMBH Neptunallee 7 C Rostock 18057 DE Other 510(k) Applications for this Company
Contact	Markus Brueggmann 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	08/27/2018
Decision Date	09/24/2018
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