The following data is part of a premarket notification filed by Roche Diabetes Care Inc. with the FDA for Accu-chek Connect Diabetes Management App.
| Device ID | K150910 |
| 510k Number | K150910 |
| Device Name: | ACCU-CHEK Connect Diabetes Management App |
| Classification | Calculator, Drug Dose |
| Applicant | ROCHE DIABETES CARE INC. 9115 HAGUE ROAD Indianapolis, IN 46250 -0457 |
| Contact | Chunhong Tao |
| Correspondent | Chunhong Tao ROCHE DIABETES CARE INC. 9115 HAGUE ROAD Indianapolis, IN 46250 -0457 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-03 |
| Decision Date | 2015-06-03 |
| Summary: | summary |