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510(k) K232895

B-Ultrasound Diagnostic System by Contec Medical Systems Co.,Ltd — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2024
Date Received
September 18, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
Review Panel
RA
Submission Type

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  • 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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