PULSION PICCO-2, MODEL 8500


Device Classification Name

computer, diagnostic, pre-programmed, single-function

510(k) Number K072735
Device Name PULSION PICCO-2, MODEL 8500
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 870.1435
Classification Product Code
DXG  
Date Received 09/27/2007
Decision Date 10/18/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No