FDA 510(k) Application Details - K080176

Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic

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510(K) Number K080176
Device Name System, Imaging, Pulsed Doppler, Ultrasonic
Applicant ALOKA CO., LTD.
10 FAIRFIELD BLVD.
WALLINGFORD, CT 06492 US
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Contact RICHARD CEHOVSKY
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Regulation Number 892.1550

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Classification Product Code IYN
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Date Received 01/24/2008
Decision Date 02/29/2008
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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