Device Classification Name |
pump, infusion
|
510(k) Number |
K880479 |
Device Name |
IMED(R) GEMINI(TM) PC-1 VOLUMETRIC INFUSION PUMP |
Applicant |
IMED CORP. |
9775 BUSINESSPARK AVE. |
SAN DIEGO,
CA
92131 -1699
|
|
Applicant Contact |
JARBOE, PHD |
Correspondent |
IMED CORP. |
9775 BUSINESSPARK AVE. |
SAN DIEGO,
CA
92131 -1699
|
|
Correspondent Contact |
JARBOE, PHD |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 02/05/1988 |
Decision Date | 04/25/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|