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510(k) K231354

Pocket Ultrasound System (C10) by Beijing Konted Medical Technology Co.,Ltd — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2023
Date Received
May 10, 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 Beijing Konted Medical Technology Co.,Ltd

  • K241979 — Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro) (August 22, 2024)

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