The following data is part of a premarket notification filed by Sanofi, Inc. with the FDA for My Dose Coach.
| Device ID | K163099 |
| 510k Number | K163099 |
| Device Name: | My Dose Coach |
| Classification | Calculator, Drug Dose |
| Applicant | Sanofi, Inc. 640 Memorial Drive Cambridge, MA 02139 |
| Contact | Robert Ezzell |
| Correspondent | Robert Ezzell Sanofi, Inc. 640 Memorial Drive Cambridge, MA 02139 |
| Product Code | NDC |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-07 |
| Decision Date | 2017-03-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04030685900001 | K163099 | 000 |