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510(k) K200780

XBit Series Digital Color Doppler Ultrasound System by CHISON Medical Technologies Co., Ltd. — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 2020
Date Received
March 25, 2020
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

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  • K201968 — SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound System (February 26, 2021)
  • K201967 — SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound System (February 26, 2021)
  • K201971 — SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound System (February 25, 2021)
  • K201969 — SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound System (February 25, 2021)
  • K180974 — CBit Series Digital Color Doppler Ultrasound System (August 17, 2018)

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