The following data is part of a premarket notification filed by Roche Diagnostics Corporation with the FDA for Accu-chek Connect Diabetes Management App.
| Device ID | K141929 |
| 510k Number | K141929 |
| Device Name: | ACCU-CHEK CONNECT DIABETES MANAGEMENT APP |
| Classification | Calculator, Drug Dose |
| Applicant | ROCHE DIAGNOSTICS CORPORATION 9115 Hague Road Indianapolis, IN 46250 |
| Contact | Chunhong(emma) Tao |
| Correspondent | Chunhong(emma) Tao ROCHE DIAGNOSTICS CORPORATION 9115 Hague Road Indianapolis, IN 46250 |
| Product Code | NDC |
| Subsequent Product Code | JQP |
| Subsequent Product Code | LFR |
| Subsequent Product Code | LZG |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-16 |
| Decision Date | 2015-03-16 |
| Summary: | summary |