Device Classification Name |
Pump, Infusion, Gallstone Dissolution
|
510(k) Number |
K993907 |
Device Name |
VIRIDIA INFORMATION CENTER SOFTWARE FOR M3154A OPT C22 |
Applicant |
AGILENT TECHNOLOGIES, INC. |
3000 MINUTEMAN RD. |
ANDOVER,
MA
01810 -1099
|
|
Applicant Contact |
DAVE OSBORN |
Correspondent |
AGILENT TECHNOLOGIES, INC. |
3000 MINUTEMAN RD. |
ANDOVER,
MA
01810 -1099
|
|
Correspondent Contact |
DAVE OSBORN |
Regulation Number | 880.5725 |
Classification Product Code |
|
Date Received | 11/17/1999 |
Decision Date | 12/06/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|