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510(k) K180155

Arm Type Blood Pressure Monitor by Avita Corporation — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 2018
Date Received
January 19, 2018
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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  • K112825 — AVITA ARM TYPE BLOOD PRESSURE MONITOR (January 18, 2012)
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Other clearances for product code DXN

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