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510(k) K242568

Wrist Blood Pressure Monitor (OHMS11, OHMS12) by Shenzhen Zhongkemingwang Telecommunications Software Corp. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 2025
Date Received
August 29, 2024
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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