FDA 510(k) Application Details - K142006

Device Classification Name System, Tomography, Computed, Emission

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510(K) Number K142006
Device Name System, Tomography, Computed, Emission
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC.
2501 NORTH BARRINGTON RD.
HOFFMAN ESTATES, IL 60192 US
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Contact CYNTHIA BUSCH
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Regulation Number 892.1200

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Classification Product Code KPS
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Date Received 07/23/2014
Decision Date 08/21/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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