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510(k) K943256

CARDIAC OUTPUT OPTION 39 by Medical Data Electronics — Product Code DXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 1994
Date Received
July 6, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Pre-Programmed, Single-Function
Device Class
Class II
Regulation Number
870.1435
Review Panel
CV
Submission Type

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