DEN170043 is an FDA 510(k) submission for the DreaMed Advisor Pro. This device is classified as a Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals (Class II - Special Controls, product code QCC).
Submitted by DreaMed Diabetes, Ltd. (Petah Tikva, Pob 3271, IL). The FDA issued a Not Cleared (DENG) decision on June 12, 2018.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1358. An Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals Is Intended To Recommend Insulin Pump Therapy Parameter Adjustments (e.g., Basal Rate, Insulin To Carbohydrate Ratios, Insulin Sensitivity Factors) Based On Data From External Devices, Including Continuous Glucose Monitors..
| 510(k) Number | DEN170043 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | August 17, 2017 |
| Decision Date | June 12, 2018 |
| Days to Decision | 299 days |
| Submission Type | Direct |
| Review Panel | Chemistry (CH) |
| Summary | - |
| Product Code | QCC - Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1358 |
| Definition | An Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals Is Intended To Recommend Insulin Pump Therapy Parameter Adjustments (e.g., Basal Rate, Insulin To Carbohydrate Ratios, Insulin Sensitivity Factors) Based On Data From External Devices, Including Continuous Glucose Monitors. |