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510(k) K230642

Electronic Blood Pressure Monitor by Dongguan Kangweile Electronic Technology Co., Ltd. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 2023
Date Received
March 8, 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

Other clearances by Dongguan Kangweile Electronic Technology Co., Ltd.

  • K212171 — Electronic Blood Pressure Monitor (November 1, 2021)

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