FDA 510(k) Application Details - K101757

Device Classification Name Transducer, Ultrasonic, Diagnostic

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510(K) Number K101757
Device Name Transducer, Ultrasonic, Diagnostic
Applicant SONOSITE,INC.
21919 30TH DRIVE SE.
BOTHELL, WA 98021-3904 US
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Contact MARY K MOORE
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Regulation Number 892.1570

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Classification Product Code ITX
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Date Received 06/23/2010
Decision Date 08/12/2010
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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