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FDA 510(k) Application Details - K131634
Device Classification Name
System, Tomography, Computed, Emission
More FDA Info for this Device
510(K) Number
K131634
Device Name
System, Tomography, Computed, Emission
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
810 INNOVATION DRIVE
KNOXVILLE, TN 37932-2751 US
Other 510(k) Applications for this Company
Contact
ELAINE CHANG
Other 510(k) Applications for this Contact
Regulation Number
892.1200
More FDA Info for this Regulation Number
Classification Product Code
KPS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/04/2013
Decision Date
08/16/2013
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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