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510(k) K112825

AVITA ARM TYPE BLOOD PRESSURE MONITOR by Avita Corporation — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 2012
Date Received
September 28, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Device Class
Class II
Regulation Number
870.1130
Review Panel
CV
Submission Type

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