Device Classification Name |
Pump, Infusion
|
510(k) Number |
K042121 |
Device Name |
SPECTRUM AND SPECTRUM WITH MASTER DRUG LIBRARY |
Applicant |
SIGMA INTL. |
711 PARK AVE. |
MEDINA,
NY
14103 -0756
|
|
Applicant Contact |
CHARLES L MARTINA |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
DERWYN REUBER |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 08/06/2004 |
Decision Date | 08/26/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|