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510(k) K181372

Argos by Retia Medical, LLC — Product Code DXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2018
Date Received
May 23, 2018
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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