FDA 510(k) Application Details - K051085

Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic

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510(K) Number K051085
Device Name System, Imaging, Pulsed Doppler, Ultrasonic
Applicant COMPUMEDICS GERMANY GMGH
JOSEF-SCHUETTLER STR. 2
SINGEN 78224 DE
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Contact GEROLD WIDENHORN
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Regulation Number 892.1550

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Classification Product Code IYN
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Date Received 04/28/2005
Decision Date 05/05/2005
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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