BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR


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
Regulation Number 870.2770
Classification Product Code
DSB  
Date Received 03/04/2011
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