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510(k) K211288

Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B by Microlife Intellectual Property GmbH — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 2021
Date Received
April 28, 2021
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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