FDA 510(k) Application Details - K991872

Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic

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510(K) Number K991872
Device Name System, Imaging, Pulsed Doppler, Ultrasonic
Applicant ECTON, INC.
110 WEST BUTLER AVE., #100
AMBLER, PA 19002-9998 US
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Contact CHRISTOPHER B KNELL
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Regulation Number 892.1550

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Classification Product Code IYN
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Date Received 06/01/1999
Decision Date 06/16/1999
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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