K141929 is an FDA 510(k) clearance for the ACCU-CHEK CONNECT DIABETES MANAGEMENT APP. This device is classified as a Calculator, Drug Dose (Class II - Special Controls, product code NDC).
Submitted by Roche Diagnostics Corporation (Indianapolos, US). The FDA issued a Cleared decision on March 16, 2015, 243 days after receiving the submission on July 16, 2014.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 868.1890.
| 510(k) Number | K141929 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 16, 2014 |
| Decision Date | March 16, 2015 |
| Days to Decision | 243 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | NDC — Calculator, Drug Dose |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1890 |