FDA 510(k) Application Details - K121689

Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic

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510(K) Number K121689
Device Name System, Imaging, Pulsed Echo, Ultrasonic
Applicant VITACON MEDICAL INC.
4020 Viking Way
Unit 130
Richmond V6V 2L4 CA
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Contact RON EVANS
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Regulation Number 892.1560

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Classification Product Code IYO
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Date Received 06/07/2012
Decision Date 09/19/2012
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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