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510(k) K232908

Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound Diagnostic System (CMS1700C) by Contec Medical Systems Co.,Ltd — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2024
Date Received
September 19, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Device Class
Class II
Regulation Number
892.1550
Review Panel
RA
Submission Type

Other clearances by Contec Medical Systems Co.,Ltd

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  • K220245 — Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) (September 28, 2022)
  • K202757 — CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, AB (April 28, 2021)
  • 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)

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