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510(k) K153077

Microlife Upper Arm Automatic Digital Blood Pressure Monitor by Microlife Intellectual Property GmbH — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2016
Date Received
October 23, 2015
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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