Home / 510(k) Clearances / K181154

510(k) K181154

Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor by Shenzhen Med-Link Electronics Tech Co., Ltd. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2019
Date Received
May 1, 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 Shenzhen Med-Link Electronics Tech Co., Ltd.

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  • K210441 — Incontinence Probe (September 17, 2021)
  • K202743 — Med-Link Temp-pulse Oximeter (March 1, 2021)
  • K193338 — Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes (August 25, 2020)
  • K182667 — Med-link Temperature Probes (June 18, 2019)
  • K173869 — Med-link Reusable Blood Pressure Cuff (August 2, 2018)
  • K160530 — Med-link Reusable Blood Pressure Cuff, Med-link Disposable Blood Pressure Cuff (November 28, 2016)

Other clearances for product code DXN

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  • K252685 — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, (February 13, 2026)
  • K251581 — Wearable Ambulatory Blood Pressure Monitor (WBP-02A) (February 13, 2026)
  • K253133 — Wrist Blood Pressure Monitor (BPM-W1VL) (February 13, 2026)
  • 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)
  • K251143 — Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L) (December 19, 2025)
  • K251331 — Blood Pressure Monitor (B73, BE23T) (October 27, 2025)
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