Device Classification Name |
pump, infusion, analytical sampling
|
510(k) Number |
K922997 |
Device Name |
VIA 1-01 INFUSION PUMP/BLOOD CHEM. SYST. -- MOD. |
Applicant |
VIA MEDICAL CORP. |
10633 ROSELLE ST. |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
DAN MCKAY |
Correspondent |
VIA MEDICAL CORP. |
10633 ROSELLE ST. |
SAN DIEGO,
CA
92121
|
|
Correspondent Contact |
DAN MCKAY |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 06/22/1992 |
Decision Date | 01/11/1994 |
Decision |
Substantially Equivalent - Kit With Drugs
(SEKD) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|