FDA 510(k) Application Details - K190447

Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic

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510(K) Number K190447
Device Name System, Imaging, Pulsed Doppler, Ultrasonic
Applicant Navigant Consulting - on behalf of Esaote S.p.A.
9100 Keystone Crossing Suite 500
Indianapolis, IN 46240 US
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Contact Allison Scott
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Regulation Number 892.1550

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Classification Product Code IYN
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Date Received 02/25/2019
Decision Date 04/01/2019
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



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