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510(k) K202757

CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure Monitor by Contec Medical Systems Co.,Ltd — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 2021
Date Received
September 21, 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 Contec Medical Systems Co.,Ltd

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  • K232895 — B-Ultrasound Diagnostic System (May 3, 2024)
  • K232908 — Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound (May 2, 2024)
  • K220245 — Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) (September 28, 2022)
  • K201980 — Infrared Thermometer (December 18, 2020)
  • K171360 — CONTEC™ Electrocardiograph (January 22, 2018)
  • K170856 — CMS600P2 B-Ultrasound Diagnostic System (November 17, 2017)
  • K170954 — Portable ECG Monitor (May 30, 2017)
  • K152863 — Portable ECG Monitor (June 22, 2016)
  • K141362 — PULSE OXIMETER CMS50EW (April 23, 2015)

Other clearances for product code DXN

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  • 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)