FDA 510(k) Application Details - K191055

Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic

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510(K) Number K191055
Device Name System, Imaging, Pulsed Doppler, Ultrasonic
Applicant Samsung Medison Co., Ltd.
3366, Hanseo-ro, Nam-myeon,
Hongcheon-gun 25108 KR
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Contact Scully Kim
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Regulation Number 892.1550

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Classification Product Code IYN
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Date Received 04/19/2019
Decision Date 06/12/2019
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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