510(k) K140771

PHILIPS ELEVA WORKSPOT by Philips Medical Systems Dmc GmbH — Product Code MQB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 2014
Date Received
March 27, 2014
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type