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510(k) K133664

ENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE DENSITOMETERS by Ge Medical Systems Ultrasound & Primary Care Diagn — Product Code KGI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 2014
Date Received
November 29, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Densitometer, Bone
Device Class
Class II
Regulation Number
892.1170
Review Panel
RA
Submission Type

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