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510(k) K152582

CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box by Volcano Corporation — Product Code DSK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 2015
Date Received
September 10, 2015
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Blood-Pressure
Device Class
Class II
Regulation Number
870.1110
Review Panel
CV
Submission Type

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