FDA 510(k) Application Details - K142100

Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic

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510(K) Number K142100
Device Name System, Imaging, Pulsed Doppler, Ultrasonic
Applicant SUPERSONIC IMAGINE
Les Jardins de la Duranne bat. E & F, 510 RUE RENE DESCARTES
AIX-EN-PROVENCE 13857 FR
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Contact AURELIE GRUENER
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Regulation Number 892.1550

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Classification Product Code IYN
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Date Received 08/01/2014
Decision Date 11/20/2014
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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