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510(k) K202599

Transtek Wrist Blood Pressure Monitor by Guangdong Transtek Medical Electronics Co., Ltd. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 2020
Date Received
September 8, 2020
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 Guangdong Transtek Medical Electronics Co., Ltd.

  • K243060 — TeleRPM Gen2 Blood Glucose Monitoring System (January 30, 2025)
  • K241351 — Blood Pressure Monitor (TMB-2092-G) (August 21, 2024)
  • K240832 — Blood Pressure Monitor (BBZ32-AA01) (June 7, 2024)
  • K240254 — Blood Pressure Monitor (TMB-2296-BT) (May 31, 2024)
  • K240102 — Blood Pressure Monitor (TMB-2287-B) (April 29, 2024)
  • K233130 — Blood Pressure Monitor (December 20, 2023)
  • K232713 — Blood Pressure Monitor (November 28, 2023)
  • K232621 — Blood pressure monitor (November 22, 2023)
  • K223374 — Blood Pressure Monitor (June 30, 2023)
  • K220676 — Blood Pressure Monitor (August 29, 2022)

Other clearances for product code DXN

  • K252779 — YUWELL® Electronic Blood Pressure Monitor (YE630CR) (March 5, 2026)
  • K253228 — YUWELL® Electronic Blood Pressure Monitor (YE650AR) (February 23, 2026)
  • 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)
  • K251795 — Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753) (October 9, 2025)