Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals
Device Code: 680
Product Code(s):
QCC 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
Device Classification Information
| Device Type ID | 680 |
| Device Name | Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals |
| Physical State | The Device Is Software With A Graphical User Interface. |
| Technical Method | Software Algorithm |
| Target Area | Diabetes |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(k) |
| CFR Regulation Number | 862.1358 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QCC |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 680 |
| Device | Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals |
| Product Code | QCC |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 862.1358 [🔎] |
TPLC Last Update: 2019-04-02 19:38:35