510(k) K191370
K191370 is an FDA 510(k) premarket notification submitted by DreaMed Diabetes, Ltd. for the device "DreaMed Advisor Pro". The FDA issued a decision of Substantially Equivalent on July 18, 2019. The device falls under product code QCC (Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals), a Class II device regulated under 21 CFR 862.1358. DreaMed Diabetes, Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 18, 2019
- Date Received
- May 22, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals
- Device Class
- Class II
- Regulation Number
- 862.1358
- Review Panel
- CH
- Submission Type
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.