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510(k) K231478

Digital Blood Pressure Monitor (Model: YB-800) by Wenzhou Yosun Medical Technology Co.,Ltd — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2023
Date Received
May 22, 2023
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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