Device Classification Name |
Pump, Infusion
|
510(k) Number |
K950419 |
Device Name |
THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETS |
Applicant |
IMED CORP. |
9775 BUSINESSPARK AVE. |
SAN DIEGO,
CA
92131 -1699
|
|
Applicant Contact |
AHMAD SAJADI |
Correspondent |
IMED CORP. |
9775 BUSINESSPARK AVE. |
SAN DIEGO,
CA
92131 -1699
|
|
Correspondent Contact |
AHMAD SAJADI |
Regulation Number | 880.5725
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/31/1995 |
Decision Date | 06/21/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|