FDA 510(k) Application Details - K223920

Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic

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510(K) Number K223920
Device Name System, Imaging, Pulsed Doppler, Ultrasonic
Applicant VINNO Technology (Suzhou) Co.,Ltd
5F Building A,4F Building C No. 27 Xinfa Rd.
Suzhou Industrial Park
Suzhou 215123 CN
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Contact Cordelia Liu
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Regulation Number 892.1550

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Classification Product Code IYN
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Date Received 12/29/2022
Decision Date 06/17/2023
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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