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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 K060898
Device Name PULSION PICCO PLUS, MODEL 8100
Applicant
Pulsion Medical Systems AG
P.O. Box 99033
Raleigh,  NC  27624
Applicant Contact Jamie Sulley
Correspondent
Pulsion Medical Systems AG
P.O. Box 99033
Raleigh,  NC  27624
Correspondent Contact Jamie Sulley
Regulation Number870.1435
Classification Product Code
DXG  
Date Received04/03/2006
Decision Date 07/25/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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