FDA 510(k) Application Details - K041947

Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic

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510(K) Number K041947
Device Name System, Imaging, Pulsed Echo, Ultrasonic
Applicant INNOVATIVE IMAGING, INC.
9940 BUSINESS PARK DR.
SUITE 155
SACRAMENTO, CA 95827 US
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Contact CYNTHIA KENDALL
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Regulation Number 892.1560

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Classification Product Code IYO
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Date Received 07/20/2004
Decision Date 08/16/2004
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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