K241979

Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)

510(k) number
K241979
Device name
Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)
Applicant
Beijing Konted Medical Technology Co.,Ltd CN
Product code
IYN — System, Imaging, Pulsed Doppler, Ultrasonic
Decision date
2024-08-22
Date received
2024-07-05
Decision
Substantially Equivalent
Clearance type
Special
Advisory committee
Radiology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain

Also available from FDA: K241979.pdf

Official FDA record: K241979
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.