FDA 510(k) Application Details - K052021

Device Classification Name Transducer, Ultrasonic, Diagnostic

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510(K) Number K052021
Device Name Transducer, Ultrasonic, Diagnostic
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC.
1230 SHOREBIRD WAY
P O BOX 7393
MOUNTAIN VIEW, CA 94039-7393 US
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Contact ISKRA MRAKOVIC
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Regulation Number 892.1570

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Classification Product Code ITX
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Date Received 07/26/2005
Decision Date 08/17/2005
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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