FDA 510(k) Application Details - K230066

Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic

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510(K) Number K230066
Device Name System, Imaging, Pulsed Doppler, Ultrasonic
Applicant Shenzhen Wisonic Medical Technology Co., Ltd.
1st, 2nd, 5th & 6th Floor, No. 6 Building
Pingshan Technology Park, Taoyuan Street, Nanshan District
Shenzhen 518055 CN
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Contact Jiang Xiaosan
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Regulation Number 892.1550

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Classification Product Code IYN
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Date Received 01/09/2023
Decision Date 09/15/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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