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
|
|
Correspondent Contact |
THOMAS BECZE |
Regulation Number | 880.5725
|
Classification Product Code |
|
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
|
|
|