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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 K112448
Device Name PULSIOFLEX
Applicant
Pulsion Medical Systems, Inc.
1511 Essex Rd.
Westbrook,  CT  06498
Applicant Contact Jamie Sulley
Correspondent
Pulsion Medical Systems, Inc.
1511 Essex Rd.
Westbrook,  CT  06498
Correspondent Contact Jamie Sulley
Regulation Number870.1435
Classification Product Code
DXG  
Date Received08/25/2011
Decision Date 09/22/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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