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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 Dr. SE
Bothell,  WA  98021 -3904
Applicant Contact JESSICA R STENBERG
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. 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
Predetermined Change
Control Plan Authorized		 No
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