INFUSION DYNAMICS POWER INFUSER MODEL M100B


Device Classification Name

pump, infusion

510(k) Number K992044
Device Name INFUSION DYNAMICS POWER INFUSER MODEL M100B
Applicant
INFUSION DYNAMICS, INC.
116 village boulevard,
suite 200
princeton, 
NJ 
08540 -5799

Applicant Contact thomas becze
Correspondent
INFUSION DYNAMICS, INC.
116 village boulevard,
suite 200
princeton, 
NJ 
08540 -5799

Correspodent Contact thomas becze
Regulation Number 880.5725
Classification Product Code
FRN  
Date Received 06/17/1999
Decision Date 09/08/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls