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510(k) K052897

GE DEFINIUM AMX 700, MODEL AMX 700 by General Electric Medical Systems — Product Code IZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 2005
Date Received
October 14, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Mobile
Device Class
Class II
Regulation Number
892.1720
Review Panel
RA
Submission Type

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