FDA 510(k) Application Details - K072676

Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic

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510(K) Number K072676
Device Name System, Imaging, Pulsed Echo, Ultrasonic
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC.
1230 SHOREBIRD WAY
MOUNTAIN VIEW, CA 94039-7393 US
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Contact MARTINA VOGT
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Regulation Number 892.1560

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Classification Product Code IYO
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Date Received 09/21/2007
Decision Date 12/18/2007
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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