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510(k) K240102

Blood Pressure Monitor (TMB-2287-B) by Guangdong Transtek Medical Electronics Co., Ltd. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2024
Date Received
January 16, 2024
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)
  • 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)
  • K202891 — Blood Pressure Monitor (March 9, 2021)

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  • K253133 — Wrist Blood Pressure Monitor (BPM-W1VL) (February 13, 2026)
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  • 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)