Device Classification Name |
pump, infusion
|
510(k) Number |
K890736 |
Device Name |
TFV-2300 INFUSION PUMP |
Applicant |
NIHON KOHDEN AMERICA, INC. |
17112 ARMSTRONG AVE. |
IRVINE,
CA
92714
|
|
Applicant Contact |
PAUL D HASFORTH |
Correspondent |
NIHON KOHDEN AMERICA, INC. |
17112 ARMSTRONG AVE. |
IRVINE,
CA
92714
|
|
Correspondent Contact |
PAUL D HASFORTH |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 02/13/1989 |
Decision Date | 07/09/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|