FDA 510(k) Application Details - K030455

Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic

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510(K) Number K030455
Device Name System, Imaging, Pulsed Doppler, Ultrasonic
Applicant PHILIPS ULTRASOUND, INC.
22100 BOTHELL EVERETT HWY.
P.O. BOX 3003
BOTHELL, WA 98041 US
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Contact LYNN HARMER
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Regulation Number 892.1550

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Classification Product Code IYN
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Date Received 02/11/2003
Decision Date 03/13/2003
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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