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510(k) K153318

Philips Eleva Workspot with SkyFlow by Philips Medical Systems Dmc GmbH — Product Code MQB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2015
Date Received
November 18, 2015
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

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