FDA 510(k) Application Details - K062247

Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic

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510(K) Number K062247
Device Name System, Imaging, Pulsed Doppler, Ultrasonic
Applicant PHILIPS ULTRASOUND, INC.
3000 MINUTEMAN RD.
ANDOVER, MA 01810 US
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Contact STEVE SINGLAR
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Regulation Number 892.1550

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Classification Product Code IYN
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Date Received 08/03/2006
Decision Date 08/18/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party Y
Expedited Review



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