FDA 510(k) Application Details - K141369

Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic

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510(K) Number K141369
Device Name System, Imaging, Pulsed Doppler, Ultrasonic
Applicant PHILIPS ULTRASOUND, INC.
22100 BOTHELL EVERETT HWY.
BOTHELL, WA 98021 US
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Contact SARASWATHI DEORA
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Regulation Number 892.1550

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Classification Product Code IYN
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Date Received 05/23/2014
Decision Date 07/02/2014
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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