FDA 510(k) Application Details - K032875

Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic

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510(K) Number K032875
Device Name System, Imaging, Pulsed Echo, Ultrasonic
Applicant ALOKA CO. LTD USA
10 FAIRFIELD BLVD.
WALLINGFORD, CT 06492 US
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Contact RICHARD J CEHOVSKY
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Regulation Number 892.1560

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Classification Product Code IYO
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Date Received 09/15/2003
Decision Date 09/30/2003
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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