PULSIOFLEX


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

Correspodent Contact jamie sulley
Regulation Number 870.1435
Classification Product Code
DXG  
Date Received 08/25/2011
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