FDA 510(k) Application Details - K220490

Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic

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510(K) Number K220490
Device Name System, Imaging, Pulsed Doppler, Ultrasonic
Applicant ImaCor Inc
50 Jericho Turnpike Suite 105
Jericho, NY 11753 US
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Contact Richard Lanzillotto
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Regulation Number 892.1550

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Classification Product Code IYN
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Date Received 02/22/2022
Decision Date 04/08/2022
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 Y
Expedited Review



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