Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals
QCC is the FDA product code for Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals, a class II device type, regulated under 21 CFR 862.1358. FDA's definition for this code reads: "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". As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QCC
- Device name
- Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals
- FDA 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.
- Regulation
- 21 CFR 862.1358
- Device class
- Class II
- Review panel
- Clinical Chemistry
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 5
- Ingested recalls
- 0
Clearances, product code QCC
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2023 | 1 |
Applicants with the most clearances
Product code QCC| Applicant | Clearances |
|---|---|
| Dreamed Diabetes Ltd | 5 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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