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510(k) K191673

Upper Arm Blood Pressure Monitor by Famidoc Technology Company Limited — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 2019
Date Received
June 24, 2019
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

Other clearances by Famidoc Technology Company Limited

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