INFINITY PICCO POD, MODEL MS16734


Device Classification Name

computer, diagnostic, pre-programmed, single-function

510(k) Number K073113
Device Name INFINITY PICCO POD, MODEL MS16734
Applicant
Draeger Medical Systems, Inc.
6 tech drive
andover, 
MA 
01810

Applicant Contact genci omari
Correspondent
Draeger Medical Systems, Inc.
6 tech drive
andover, 
MA 
01810

Correspodent Contact genci omari
Regulation Number 870.1435
Classification Product Code
DXG  
Date Received 11/05/2007
Decision Date 01/03/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No