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FDA 510(k) Application Details - K210173
Device Classification Name
System, Tomography, Computed, Emission
More FDA Info for this Device
510(K) Number
K210173
Device Name
System, Tomography, Computed, Emission
Applicant
GE Healthcare
4 Hayozma Street
Tirat Hacarmel 30200 IL
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Contact
George Mashour
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
01/22/2021
Decision Date
03/29/2021
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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