FDA 510(k) Application Details - K241979

Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic

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510(K) Number K241979
Device Name System, Imaging, Pulsed Doppler, Ultrasonic
Applicant Beijing Konted Medical Technology Co.,Ltd
Room 111, Building 3, No. 27,Yongwang Road, Daxing
Biological Pharmaceutial Industry Base Daxing District
Beijing 102629 CN
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Contact Deyi Zhu
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Regulation Number 892.1550

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Classification Product Code IYN
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Date Received 07/05/2024
Decision Date 08/22/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review

FDA Source Information for K241979


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