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510(k) K183491

Arm Blood Pressure Monitor by Xuzhou Yongkang Electronic Science Technology Co., Ltd. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 2019
Date Received
December 17, 2018
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 Xuzhou Yongkang Electronic Science Technology Co., Ltd.

  • K191571 — UV Radiation Treatment System (February 6, 2020)
  • K180314 — Infrared Thermometer (July 11, 2018)
  • K162616 — Wrist Type Blood Pressure Monitor (March 9, 2018)
  • K161938 — Fingertip Pulse Oximeter (May 8, 2017)

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