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510(k) K162616

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 2018
Date Received
September 20, 2016
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.

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  • K183491 — Arm Blood Pressure Monitor (March 24, 2019)
  • K180314 — Infrared Thermometer (July 11, 2018)
  • K161938 — Fingertip Pulse Oximeter (May 8, 2017)

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