ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION


Device Classification Name

pump, infusion

510(k) Number K110535
Device Name ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION
Applicant
CAREFUSION 303,INC.
10020 pacific mesa blvd
san diego, 
CA 
92121

Applicant Contact gabriela muranevici
Correspondent
CAREFUSION 303,INC.
10020 pacific mesa blvd
san diego, 
CA 
92121

Correspodent Contact gabriela muranevici
Regulation Number 880.5725
Classification Product Code
FRN  
Date Received 02/25/2011
Decision Date 03/26/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No