FDA 510(k) Application Details - K032620

Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic

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510(K) Number K032620
Device Name System, Imaging, Pulsed Doppler, Ultrasonic
Applicant GENERAL ELECTRIC CO.
P.O. BOX 414
MILWAUKEE, WI 53201 US
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Contact ALLEN SCHUH
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Regulation Number 892.1550

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Classification Product Code IYN
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Date Received 08/26/2003
Decision Date 10/10/2003
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 N
Expedited Review



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