FDA 510(k) Application Details - K140251

Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)

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510(K) Number K140251
Device Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant MERIDIAN MEDICAL SYSTEMS, LLC
325 HARRIS DRIVE
AURORA, OH 44202 US
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Contact LARRY CORNELL
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Regulation Number 892.1650

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Classification Product Code MQB
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Date Received 01/31/2014
Decision Date 10/22/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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