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510(k) K902927

DIGITAL PHOTOSPOT by Eigen — Product Code JAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1990
Date Received
July 3, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Fluoroscopic, Image-Intensified
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type

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