FDA 510(k) Application Details - K162483

Device Classification Name System, Tomography, Computed, Emission

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510(K) Number K162483
Device Name System, Tomography, Computed, Emission
Applicant SIEMENS MEDICAL SOLUTIONS, USA, INC.
2501 N. BARRINGTON ROAD
Hoffman Estates, IL 60192-2061 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 09/06/2016
Decision Date 01/09/2017
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



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