Device Classification Name |
calculator, drug dose
|
510(k) Number |
K171230 |
Device Name |
My Dose Coach |
Applicant |
Sanofi |
640 Memorial Drive |
Cambridge,
MA
02142
|
|
Applicant Contact |
Robert Ezzell |
Correspondent |
Sanofi |
640 Memorial Drive |
Cambridge,
MA
02142
|
|
Correspondent Contact |
Robert Ezzell |
Regulation Number | 868.1890
|
Classification Product Code |
|
Date Received | 04/27/2017 |
Decision Date | 05/26/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|