K150910 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 Diabetes Care, Inc. (Indianapolis, US). The FDA issued a Cleared decision on June 3, 2015, 61 days after receiving the submission on April 3, 2015.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 868.1890.
| 510(k) Number | K150910 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 03, 2015 |
| Decision Date | June 03, 2015 |
| Days to Decision | 61 days |
| Submission Type | Special |
| 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 |