FDA 510(k) Application Details - K002533

Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic

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510(K) Number K002533
Device Name System, Imaging, Pulsed Doppler, Ultrasonic
Applicant SPENCER TECHNOLOGIES
701 16TH AVE.
SEATTLE, WA 98122 US
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Contact TONY WILLIAMS
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Regulation Number 892.1550

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Classification Product Code IYN
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Date Received 08/16/2000
Decision Date 08/30/2000
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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