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510(k) K230176

Upper Arm Blood Pressure Monitor by Shenzhen Yolanda Technology Co., Ltd. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 2023
Date Received
January 23, 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 Shenzhen Yolanda Technology Co., Ltd.

  • K221211 — Infrared thermometer (September 27, 2022)
  • K221212 — Upper Arm Blood Pressure Monitor (August 26, 2022)

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