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510(k) K183469

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 2019
Date Received
December 14, 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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