PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE


Device Classification Name

computer, diagnostic, pre-programmed, single-function

510(k) Number K122121
Device Name PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE
Applicant
PULSION MEDICAL SYSTEMS SE
1511 essex rd
westbrook, 
CT 
06498

Applicant Contact jamie sulley
Correspondent
PULSION MEDICAL SYSTEMS SE
1511 essex rd
westbrook, 
CT 
06498

Correspodent Contact jamie sulley
Regulation Number 870.1435
Classification Product Code
DXG  
Date Received 07/17/2012
Decision Date 08/02/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No