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510(k) K221212

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2022
Date Received
April 27, 2022
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.

  • K230176 — Upper Arm Blood Pressure Monitor (June 29, 2023)
  • K221211 — Infrared thermometer (September 27, 2022)

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