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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name computer, diagnostic, pre-programmed, single-function
510(k) Number K122121
Device Name PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE
Original Applicant
PULSION MEDICAL SYSTEMS SE
1511 essex rd
westbrook,  CT  06498
Original Contact jamie sulley
Regulation Number870.1435
Classification Product Code
DXG  
Date Received07/17/2012
Decision Date 08/02/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
statement statement
Type Special
Reviewed by Third Party No
Combination Product No
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