FDA 510(k) Application Details - K020353

Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic

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510(K) Number K020353
Device Name System, Imaging, Pulsed Doppler, Ultrasonic
Applicant SIEMENS MEDICAL SYSTEMS, INC.
22010 SE 51ST ST.
ISSAQUAH, WA 98029 US
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Contact JUDI HOFFMAN
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Regulation Number 892.1550

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Classification Product Code IYN
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Date Received 02/04/2002
Decision Date 02/13/2002
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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