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510(k) K210768

Wrist Blood Pressure Monitor, Blood Pressure Monitor by Andon Health Co, Ltd. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2021
Date Received
March 15, 2021
Clearance Type
Abbreviated
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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