PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES


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

Correspodent Contact jamie sulley
Regulation Number 870.1915
Classification Product Code
KRB  
Date Received 08/22/2007
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