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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe, Thermodilution
510(k) Number K072364
Device Name PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES
Applicant
Pulsion Medical Systems AG
7220 Sparhawk Rd.
Wake Forest,  NC  27587
Applicant Contact Jamie Sulley
Correspondent
Pulsion Medical Systems AG
7220 Sparhawk Rd.
Wake Forest,  NC  27587
Correspondent Contact Jamie Sulley
Regulation Number870.1915
Classification Product Code
KRB  
Date Received08/22/2007
Decision Date 09/19/2007
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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