FDA 510(k) Application Details - K110645

Device Classification Name Plethysmograph, Impedance

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510(K) Number K110645
Device Name Plethysmograph, Impedance
Applicant SONOSITE,INC.
21919 30TH DRIVE SE.
BOTHELL, WA 98021-3904 US
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Contact JESSICA R STENBERG
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Regulation Number 870.2770

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Classification Product Code DSB
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Date Received 03/04/2011
Decision Date 06/03/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review



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