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510(k) K812966

400T ECT SOFTWARE by General Electric Co. — Product Code JWM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1981
Date Received
October 22, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Tomographic, Nuclear
Device Class
Class II
Regulation Number
892.1310
Review Panel
RA
Submission Type

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