FDA 510(k) Application Details - K170904

Device Classification Name System, Tomography, Computed, Emission

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510(K) Number K170904
Device Name System, Tomography, Computed, Emission
Applicant Siemens Medical Solutions USA, Inc.
810 Innovation Drive
Knoxville, TN 37932 US
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Contact Alaine Medio
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Regulation Number 892.1200

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Classification Product Code KPS
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Date Received 03/28/2017
Decision Date 06/01/2017
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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