FDA 510(k) Application Details - K160357

Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic

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510(K) Number K160357
Device Name System, Imaging, Pulsed Doppler, Ultrasonic
Applicant KOELIS
5 Avenue du Grand Sablon
La Tronche 38700 FR
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Contact LAETITIA GERVAIS
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Regulation Number 892.1550

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Classification Product Code IYN
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Date Received 02/08/2016
Decision Date 05/02/2016
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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