Device Classification Name |
pump, infusion, insulin
|
510(k) Number |
K031738 |
Device Name |
SMITHS MEDICAL INSULIN INFUSION PUMP WITH COZMONITOR GLUCOSE METER |
Applicant |
SMITHS MEDICAL MD, INC. |
1265 GREY FOX ROAD |
ST. PAUL,
MN
55112
|
|
Applicant Contact |
RUSS DAVIES |
Correspondent |
SMITHS MEDICAL MD, INC. |
1265 GREY FOX ROAD |
ST. PAUL,
MN
55112
|
|
Correspondent Contact |
RUSS DAVIES |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 06/04/2003 |
Decision Date | 05/27/2004 |
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
|
|
|