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510(k) K132528

E-PICCO CONTINUOUS CARDIAC OUTPUT MODULE AND ACCESSORIES by GE Healthcare Finland Oy — Product Code DXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 2014
Date Received
August 12, 2013
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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  • K183394 — CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO (May 1, 2019)

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