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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name plethysmograph, impedance
510(k) Number K110645
Device Name BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR
Applicant
SONOSITE,INC.
21919 30TH DRIVE SE.
BOTHELL,  WA  98021 -3904
Applicant Contact JESSICA R STENBERG
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Regulation Number870.2770
Classification Product Code
DSB  
Date Received03/04/2011
Decision Date 06/03/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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