510(k) K222888
K222888 is an FDA 510(k) premarket notification submitted by Welldoc, Inc. for the device "BlueStar CGM insulin dose calculator". The FDA issued a decision of Substantially Equivalent on August 11, 2023. The device falls under product code QRX (Continuous Glucose Monitor Informed Insulin Dose Calculator), a Class II device regulated under 21 CFR 862.1358. Welldoc, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 11, 2023
- Date Received
- September 23, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Continuous Glucose Monitor Informed Insulin Dose Calculator
- Device Class
- Class II
- Regulation Number
- 862.1358
- Review Panel
- CH
- Submission Type
A continuous glucose monitor (CGM)-informed insulin dose calculator is a software device that calculates suggested insulin doses based on CGM values and/or other relevant information.