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510(k) K890745

SC-1000 WITH SUFFIXES (SCAN CONVERTER) by Eigen — Product Code JAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 1989
Date Received
February 13, 1989
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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