Device Classification Name |
pump, infusion
|
510(k) Number |
K803078 |
Device Name |
SIMPLICITY INFUSION PUMP MODEL 2100A |
Applicant |
CRITIKON COMPANY,LLC |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
CRITIKON COMPANY,LLC |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 12/05/1980 |
Decision Date | 01/28/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|