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510(k) K210671

Digital Blood Pressure Monitor WBP Series, including: WBP101, WBP102, WBP103, WBP104, WBP105, WBP106, WBP107 by Weony (Shenzhen) Technology Co., Ltd. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2021
Date Received
March 5, 2021
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 Weony (Shenzhen) Technology Co., Ltd.

  • K231542 — Digital Blood Pressure Monitor WBP Series (September 7, 2023)

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  • K251307 — Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i) (January 12, 2026)
  • K253142 — Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8D,RN3D,MJ4D,RN1D,RN2D) (January 9, 2026)