Device Classification Name |
Calculator, Drug Dose
|
510(k) Number |
K150910 |
Device Name |
ACCU-CHEK Connect Diabetes Management App |
Applicant |
ROCHE DIABETES CARE INC. |
9115 HAGUE ROAD |
INDIANAPOLIS,
IN
46250 -0457
|
|
Applicant Contact |
CHUNHONG TAO |
Correspondent |
ROCHE DIABETES CARE INC. |
9115 HAGUE ROAD |
INDIANAPOLIS,
IN
46250 -0457
|
|
Correspondent Contact |
CHUNHONG TAO |
Regulation Number | 868.1890
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/03/2015 |
Decision Date | 06/03/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|