Device Classification Name |
pump, infusion, insulin
|
510(k) Number |
K042887 |
Device Name |
ACCU-CHEK SPIRIT |
Applicant |
DISETRONIC MEDICAL SYSTEMS AG |
KIRCHBERGSTRASSE 190 |
BURGDORF,
CH
3401
|
|
Applicant Contact |
Scott Thiel |
Correspondent |
DISETRONIC MEDICAL SYSTEMS AG |
KIRCHBERGSTRASSE 190 |
BURGDORF,
CH
3401
|
|
Correspondent Contact |
Scott Thiel |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 10/19/2004 |
Decision Date | 03/18/2005 |
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
|
|
|