Device Classification Name |
calculator, drug dose
|
510(k) Number |
K163099 |
Device Name |
My Dose Coach |
Applicant |
Sanofi, Inc. |
640 Memorial Drive |
cambridge,
MA
02139
|
|
Applicant Contact |
robert ezzell |
Correspondent |
Sanofi, Inc. |
640 Memorial Drive |
cambridge,
MA
02139
|
|
Correspondent Contact |
robert ezzell |
Regulation Number | 868.1890
|
Classification Product Code |
|
Date Received | 11/07/2016 |
Decision Date | 03/22/2017 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
General Hospital
|
statement |
statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|