K232722 is an FDA 510(k) clearance for the endo.digital Platform. 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, IL). The FDA issued a Cleared decision on October 3, 2023, 28 days after receiving the submission on September 5, 2023.
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 | K232722 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 05, 2023 |
| Decision Date | October 03, 2023 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| 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. |